Gasvormige Medicinale Zuurstof Air Products

Hauptinformation

  • Handelsname:
  • Gasvormige Medicinale Zuurstof Air Products Gas zur medizinischen Anwendung, druckverdichtet 100% v/v
  • Dosierung:
  • 100% v/v
  • Darreichungsform:
  • Gas zur medizinischen Anwendung, druckverdichtet
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Gasvormige Medicinale Zuurstof Air Products Gas zur medizinischen Anwendung, druckverdichtet 100% v/v
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • medizinische Gase

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE190942
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR DEN ANWENDER

Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS, 100% v/v, medizinisches gas,

druckverdichtet

Wirkstoff: Sauerstoff

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw. genau

nach Anweisung Ihres Arztes oder Apothekers an.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Fragen Sie Ihren Apotheker, wenn Sie weitere Informationen oder einen Rat benötigen.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt

auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt

Wenn Sie sich nicht besser oder gar schlechter fühlen, wenden Sie sich an Ihren Arzt.

Was in dieser Packungsbeilage steht

Was ist Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS und wofür wird es

angewendet?

Was sollten Sie vor der Anwendung von Sauerstoff für medizinische Zwecke, gasförmig, AIR

PRODUCTS beachten?

Wie ist Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

WAS IST SAUERSTOFF FÜR MEDIZINISCHE ZWECKE, GASFÖRMIG, AIR

PRODUCTS UND WOFÜR WIRD ES ANGEWENDET?

Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS ist ein Inhalationsgas.

Arzneimittelgruppe: Sauerstofftherapie und Aerosoltherapie

In welchem Fällen das Arzneimittel angewenden ist:

Sauerstofftherapie bei Atemstörungen:

Chronische Bronchitis

Asthma

Chronisch obstruktive Atemwegserkrankungen

Aerosoltherapie

2.

WAS SOLLTEN SIE VOR DER ANWENDUNG VON SAUERSTOFF FUR

MEDIZINISCHE ZWECKE, GASFÖRMIG, AIR PRODUCTS BEACHTEN?

Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS darf nicht angewendet

werden,

bei Patienten mit einem erhöhten Pa CO2

bei Intoxikationen durch Substanzen, die die Atemtätigkeit verringern

bei gestörter Atmungssteuerung auf der Ebene des zentralen Nervensystems

07/2015

Warnhinweise und Vorsichtsmaßnahmen

In einigen Ausnahmefällen darf bei der Sauerstofftherapie nur eine geringe Menge verabreicht

werden: Befolgen Sie genau die Anweisungen des Arztes. Fragen Sie bei Unklarheiten unbedingt

Ihren Arzt oder Apotheker um Rat.

Wenden Sie dieses Arzneimittel umsichtig an: Sauerstoff für medizinische Zwecke, gasförmig, AIR

PRODUCTS ist ein stark brandfördernder Stoff unter Überdruck (200 bar). Beachten Sie genau die

auf dem Druckbehältnis/dem Bündel angegebenen Anweisungen.

Sauerstoff: Ein oxidierendes Produkt

Als ein sich oxidierendes Produkt fördert Sauerstoff die Entflammung, so dass folgende Anweisungen

zu befolgen sind:

Die Sauerstoffdruckbehältnisse/Bündel müssen in einem gut belüfteten Raum aufbewahrt

werden;

In der Nähe der Sauerstoffdruckbehältnisse /Bündel darf nicht geraucht werden;

Brennbare Gegenstände müssen ferngehalten werden;

Wärmequellen oder Flammen müssen ferngehalten werden;

Keine Fette oder Öl verwenden..

Sauerstoff: Ein verdichtetes Produkt unter Druck

Die Sauerstoffdruckbehältnisse stehen unter Überdruck (200 bar):

Die Sauerstoffdruckbehältnisse /Bündel müssen auf einem vollkommen flachen Untergrund

aufgestellt werden, und die Sauerstoffdruckbehältnisse sind gut zu befestigen, um ein

eventuelles Umfallen zu vermeiden.

Vor dem Öffnen des Ventils ist zu überprüfen, ob die Anschlüsse an das Leitungsnetz der

Versorgungseinrichtung oder an das Sauerstoffzufuhrgerät im Fall einer Lieferung nach Hause

in Ordnung sind.

Das Öffnen des Ventils muss langsam und schrittweise erfolgen.

Die Sauerstofftherapie hat keinerlei Einfluss auf das Ergebnis von Dopingkontrollen.

Besondere Vorsichtsmaßnahmen für Familienmitglieder und Pflegepersonal

Es ist absolut notwendig, dass der Raum, in dem mit dem Sauerstoff hantiert wird, ausreichend

belüftet ist, denn ein längeres Ausgesetztsein an eine Atmosphäre mit hoher Sauerstoffkonzentration

kann zu Lungenschädigungen führen.

Anwendung von Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS mit anderen

Arzneimitteln

Es sind keinerlei Wechselwirkungen zwischen Sauerstoff und anderen Arzneimitteln bekannt.

Informieren Sie Ihren Arzt oder Apotheker wenn Sie andere Arzneimittel anwenden, kürzlich andere

Arzneimittel angewendet haben oder beabsichtigen andere Arzneimittel anzuwenden.

Anwendung von Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS zusammen

mit Nahrungsmitteln und Getränken

Nicht zutreffend.

Schwangerschaft, Stillzeit und Zeugungs-/Gebärfähigkeit

Es besteht keinerlei Kontraindikation für eine Sauerstofftherapie während der Schwangerschaft.

Es besteht keinerlei Kontraindikation für eine Sauerstofftherapie während der Stillzeit.

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt

oder Apotheker um Rat.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

07/2015

Die Sauerstofftherapie führt nicht zu einer Verringerung der Aufmerksamkeit beim Lenken von

Fahrzeugen und Bedienen von Maschinen.

3.

WIE IST SAUERSTOFF FUR MEDIZINISCHE ZWECKE, GASFÖRMIG, AIR

PRODUCTS ANZUWENDEN?

Wenden Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt oder Apotheker an.

Fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Dosierung

Beachten Sie die Anweisungen des Arztes bezüglich Menge und Dauer der täglichen Anwendung. Die

Dosierung ist an den jeweilige Patienten anzupassen und abhängig zu machen von der klinischen

Entwicklung. Die Dosierung kann zwischen 1 und 10 Liter pro Minute variieren und über die Dauer

von 15 bis 24 Stunden pro Tag beibehalten werden.

Häufigkeit und Zeitpunkt der Verabreichung des Arzneimittels

Die Behandlung mittels Sauerstofftherapie wird an jeden Patienten individuell angepasst.

Die Unterschiede können in der Durchflussmenge liegen.Die Therapie kann mit Unterbrechungen

oder kontinuierlich 24 Stunden hinweg angewendet werden. Angesichts der verschiedenen

Möglichkeiten bei der Behandlung ist es ratsam, die Anweisungen des Arztes genau zu befolgen.

Art der Verabreichung

Respiratorische Therapie.

Das Arzneimittel ist für die Luftwege bestimmt und wird über diese mittels einer Apparatur

verabreicht, wie sie bei einer Sauerstofftherapie eingesetzt wird (d. h. Maske oder Nasenkatheter).

Verwendung der Materialien

Jedes noch unbenutzte Druckbehältnis ist mit einem Deckel oder Schrumpffolie versehen, wodurch

der Ventilanschluss geschützt und Bedienungsfehler verhindert werden. Dieser Schutz muss also beim

ersten Gebrauch noch unbeschädigt sein und ist zu entfernen, um das benötigte Gerät montieren zu

können.

Die Materialien sind für den ausschließlichen Gebrauch mit medizinischen Geräten speziell für

Sauerstoffgas bestimmt.

Die Verwendung von Fett oder Öl beim Anschließen der Geräte an den Ventilanschluss ist strikt

untersagt.

Die Geräte müssen von Hand montiert werden ohne Kraftanwendung und somit ohne Werkzeug.

Bei dem standardmäßigen, mit Handrad versehenen Ventil wird ein Druckregler auf das

Druckbehältnis montiert, wonach ein Gerät befestigt wird, mithilfe dessen die Durchflussmenge an

Sauerstoffgas geregelt wird.

Im Falle eines integrierten Ventils gelten folgende Gebrauchsvorschriften: Siehe Label.

Die bei dem Patienten anwendbare Autonomie hängt von der Größe des

Druckbehältnisses ab.

Autonomie des 1 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 1 Liter enhält 0,2 m

(213 l) Gas unter einem Druck von 1 bar bei 15 °C

Druckbeh

ältnis von

0,2m

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druck (bar)

3h20

2h10

1h40

1h06

0h50

0H33

0H22

0H16

0H13

2H30

1H40

1H15

0H50

0H37

0H24

0H16

0H12

0H10

1H40

1H06

0H50

0H33

0H24

0H16

0H11

0H08

0H06

0H50

0H33

0H24

0H16

0H12

0H08

0H06

0H04

0H03

07/2015

Autonomie des 2 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 2 Liter enthält 0,4 m

(425 l) Gas unter einem Druck von 1 bar bei 15

Druckbeh

ältnis von

0,4m

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druck (bar)

6h40

4h25

3h20

2h10

1h40

1h05

0h40

0h30

0h25

5h00

3h20

2h30

1h40

1h15

0h50

0h30

0h25

0h20

3h20

2h10

1h25

1h05

0h50

0h30

0h20

0h15

0h10

1h40

1h05

0h50

0h30

0h25

0h15

0h10

0h08

0h06

Autonomie des 5 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 5 Liter enhält 1 m

(1063 l) Gas unter einem Druck von 1 bar bei 15 °C

Druckbeh

ältnis von

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druck (bar)

16h40

11h05

8h20

5h30

4h10

2h45

1h50

1h20

1h05

12h30

8h20

6h15

4h10

3h05

2h00

1h20

1h00

0h50

8h20

5h30

4h10

2h45

2h00

1h20

0h55

0h40

0h30

4h10

2h45

2h00

1h20

1h00

0h40

0h25

0h20

0h15

Autonomie des 10 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 10 Liter enhält 2,1 m

(2127 l) Gas unter einem Druck von 1 bar bei

15°C

Druckbeh

ältnis von

2,1m

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druck (bar)

33h20

22h10

16h20

11h05

8h20

5h00

3h40

2h45

2h10

25h00

16h40

12h30

8h20

6h15

4h10

2h45

2h05

1h40

16h40

11h05

8h20

5h00

4h10

2h15

1h50

1h20

1h05

8h20

5h00

4h10

2h15

2h05

1h20

0h55

0h40

0h30

Autonomie des 15 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 15 Liter enhält 3,1 m

(3190 l) Gas unter einem Druck von 1 bar bei

15°C

Druckbehält

nis von 3,1

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druk (bar)

50h00

33h20

25h00

16h20

12h30

8h20

5h30

4h10

3h20

37h30

25h00

18h45

12h30

9h20

6h15

4h10

3h05

2h30

25h00

16h40

12h30

8h20

6h15

6h15

4h10

3h05

2h30

12h30

8h20

6h15

4h10

3h05

2h00

1h20

1h00

0h50

07/2015

Autonomie des 20 Liter-Druckbehältnisses bezüglich Durchflussmenge und Druck

1 Druckbehältnis von 20 Liter enhält 4,3 m

(4254 l) Gas unter einem Druck von 1 bar bei 15

Druckbeh

ältnis von

4,3m

Durchflussmenge in Liter/Minute

1 1.5 2 3 4 6 9 12 15

Druck (bar)

66h40

44h25

33h20

22h10

16h40

11h05

7h20

5h30

4h25

50h00

33h20

25h00

16h40

12h30

8h20

5h30

4h10

3h20

33h20

22h10

16h40

11h05

8h20

5h30

3h40

2h45

2h10

16h40

11h05

8h20

5h30

4h10

2h45

1h50

1h20

1h05

Dauer der Behandlung

Ihr Arzt wird Ihnen mitteilen, wie lange Sie den Sauerstoff anwenden müssen. Beenden Sie die

Behandlung nicht frühzeitig, denn möglicherweise müssen Sie den Sauerstoff über längere Zeit

hinweg anwenden.

Die Anpassung der Behandlung an den jeweiligen Patienten bezieht sich auch auf die Dauer der

Behandlung:

- variable Dauer der Sauerstofftherapie während des Tages

- variable Zeitdauer der Sauerstofftherapie abhängig vom chronischen Charakter der Krankheit.

Es ist ratsam, die Dauer der Behandlung streng nach Anweisungen des Arztes einzuhalten.

Wenn Sie eine größere Menge von Sauerstoff für medizinische Zwecke, gasförmig, AIR

PRODUCTS angewendet haben, als Sie sollten

Wenn Sie zu viel Sauerstoff angewendet haben, wenden Sie sich bitte umgehend an Ihren Arzt,

Apotheker oder die zuständige Giftnotrufzentrale (070/245.245).

Sauerstoff kann in reiner Form (d. h. 100 %) verabreicht werden, je nach Krankheitsbild des

Patienten, ohne dass Anzeichen einer Überdosierung zu erkennen sind.

In diesem Fall kann es zu ungewünschten Wirkungen kommen, die mit einer zu hohen

Sauerstoffkonzentration und einem zu langen Ausgesetztsein an diese Konzentration

zusammenhängen (siehe 4. “Welche Nebenwirkungen sind möglich?”).

Wenn Sie die Anwendung von Sauerstoff für medizinische Zwecke, gasförmig, AIR

PRODUCTS vergessen haben

Das Nichteinhalten der Anweisungen verringert die Wirksamkeit der Behandlung.

Es wird daher dringend geraten, die Anweisungen des Arztes zu befolgen, um so bei dem Patienten

eine gute Besserung der Atmung zu gewährleisten.

Nehmen Sie nicht die doppelte Dosis ein, wenn Sie die vorherige Einnahme vergessen haben.

Wenn Sie die Anwendung von Sauerstoff für medizinische Zwecke, gasförmig, AIR

PRODUCTS abbrechen

Beraten Sie sich immer mit Ihrem Arzt, wenn Sie eine Beendigung in Erwägung ziehen.

Wenn Sie weitere Fragen zur Anwendung des Arzneimittels haben, fragen Sie Ihren Arzt oder

Apotheker.

4.

WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

07/2015

Es sind Fälle von Netzhauterkrankungen, Lungenschäden und Hyperventilation bekannt.

Diese unerwünschten Wirkungen wurden hauptsächlich bei langfristigen Behandlungen mit hohen

Sauerstoffkonzentrationen beobachtet.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies

gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Sie

können Nebenwirkungen auch direkt über das nationale Meldesystem anzeigen:

Föderalagentur für Arzneimittel und Gesundheitsprodukte

Abteilung Vigilanz

Eurostation II

Victor Hortaplein, 40/40

B-1060 BRUSSEL

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen

über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

WIE IST SAUERSTOFF FUR MEDIZINISCHE ZWECKE, GASFORMIG, AIR

PRODUCTS AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen das Arzneimittel nach dem auf dem Etikett nach EXP angegebenen Verfalldatum nicht

mehr verwenden. Das Verfalldatum bezieht sich auf den letzten Tag des Monats.

Besondere Lagerungsvorschriften

Befolgen Sie die Benutzeranweisungen für die Lagerung gemäß Abschnitt “Warnhinweise und

Vorsichtsmaßnahmen”.

Beachtung sichtbarer Hinweise auf Beschädigung

Wenn ein Druckbehältnis Zeichen von Stößen, Dellen oder andere Verformungen aufweist, müssen

diese Schäden dem Hersteller gemeldet werden, damit das Druckbehältnis vollständig aus dem

Verkehr gezogen werden kann.

6.

INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS enthält

Der Wirkstoff ist: Sauerstoff

Es gibt keine sonstigen Bestandteile.

07/2015

Wie Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS aussieht und Inhalt der

Packung

Sauerstoff für medizinische Zwecke, gasförmig, AIR PRODUCTS ist farb- und geruchlos.

DARREICHUNG

(Druckbehältnis und Bündel)

SAUERSTOFFMENGE

(m

3

)

WASSERKAPAZITÄT *

(Liter)

B 01

B 02

B 05

B 10

B 15

B 20

B 50

BÜNDEL 11 B 50

BÜNDEL 20 B 50

10,7

117,7

1000

* Wasserkapazität: +/- 3% (Toleranz bei der Herstellung von Druckbehältnissen)

Der Ventilanschluss des Druckbehältnisses ist mit einem Deckel oder Schrumpffolie versehen,

wodurch der Ventilanschluss geschützt und Bedienungsfehler vermieden werden.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer

AIR PRODUCTS SA/NV

Leonardo da Vincilaan 19

1831 Diegem, Belgien

Tel.: 02/674 94 11

Fax: 02/663 42 00

Hersteller

AIR PRODUCTS S.A.S.

Zone Industrielle de l’Epinoy

59175 Templemars, France

Zulassungsnummer:

BE217402 (Druckbehältnis mit standardventil)

BE343122 (Druckbehältnis mit integriertem Druckminderer)

BE190942 (Bündel)

Verkaufsabgrenzung: Apothekenpflichtig

Diese Packungsbeilage wurde zuletzt genehmigt im 08/2015.

07/2015

15-11-2018

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

8-11-2018

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

2-11-2018

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.

FDA - U.S. Food and Drug Administration

2-11-2018

Brin de Folie recalls Wind-up Racoon Toys

Brin de Folie recalls Wind-up Racoon Toys

Health Canada's sampling and evaluation program has determined that the affected products do not meet the Canadian safety requirements for toys. The tail can detach from the toy, posing a choking hazard to young children.

Health Canada

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

30-10-2018

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

FDA’s Plant & Animal Biotechnology Innovation Action Plan ensures the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation. Key elements: Veterinary Innovation Program, public webinar on genome editing in animals & release of future guidance.

FDA - U.S. Food and Drug Administration

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Nutrition Facts Label Reboot: A Tale of Two Labels

Nutrition Facts Label Reboot: A Tale of Two Labels

The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize...

FDA - U.S. Food and Drug Administration

25-10-2018

Xylitol and Your Dog: Danger, Paws Off

Xylitol and Your Dog: Danger, Paws Off

This sugar substitute, found in some human foods and dental products, can be poisonous to your dog.

FDA - U.S. Food and Drug Administration

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of "Chocolate Whoopie Pie" because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

25-10-2018

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes linked to consumption of salmon products

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

24-10-2018

U-Pol Inc. recalls Automotive Repair and Refinish Products

U-Pol Inc. recalls Automotive Repair and Refinish Products

Health Canada has established that these products do not meet the mandatory warning labelling requirements for consumer use, as required under Canadian law. They are correctly labelled for workplace professional users, but the products lack the symbols and warnings required for consumer chemicals.

Health Canada

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products

FDA - U.S. Food and Drug Administration

23-10-2018

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

23-10-2018

Zeagle recalls Sport Buoyancy Control Device Inflators

Zeagle recalls Sport Buoyancy Control Device Inflators

There exists a possibility that buttons on the Zeagle Sport BCD inflators may break or fracture leading to a rapid loss of air or auto inflation of the BCD, posing a potential drowning hazard.

Health Canada

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

19-10-2018

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (soy). People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

10-10-2018

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

13-11-2018

Health information for those affected by #WoolseyFire is available on our website at:  http://publichealth.lacounty.gov/media/FireSafety …
- Food safety
- Ash clean-up
- Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air quality pic.twitter.com/8HC7NoLaXB

FDA - U.S. Food and Drug Administration

21-10-2018

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding  ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding ht

Although I’ve been focusing on medical products, we're also advancing our food safety and nutrition work, such as our joint advice w/ EPA on making informed choices about eating fish for women who are pregnant, may become pregnant or are breastfeeding https://go.usa.gov/xPnda . pic.twitter.com/nktV9BDAC3

FDA - U.S. Food and Drug Administration

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety