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  • Εμπορική ονομασία:
  • PROSPAN 65MG/TAB EF.TAB
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  • R07AX
  • Δοσολογία:
  • 65MG/TAB
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  • ΑΝΑΒΡΑΖΟΝ ΔΙΣΚΙΟ
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  • PROSPAN 65MG/TAB EF.TAB
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Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΑ ΠΡΟΪΟΝΤΑ ΦΥΤΙΚΗΣ ΠΡΟΕΛΕΥΣΗΣ

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • τελευταία ενημέρωση:
  • 09-08-2016

Περίληψη των χαρακτηριστικών του προϊόντος

ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ

P R O S P A N P R O S P A N

Αναβράζοντα δισκία, Πόσιμο διάλυμα,

Dried Ivy Leaf Extract  65 mg/tab, 35 mg /5ml

1.  ΕΜΠΟΡΙΚΗ ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ  ΠΡΟΪΟΝΤΟΣ

P R O S P A N P R O S P A N

2.  ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ ΣΕ ΔΡΑΣΤΙΚΑ ΣΥΣΤΑΤΙΚΑ

          Ξηρό εκχύλισμα φύλλων κισσού 65 mg/tab 

          Ξηρό εκχύλισμα φύλλων κισσού 35 mg/ 5ml

   

  Για τον πλήρη κατάλογο των εκδόχων, δείτε τμήμα 6.1

3.   ΦΑΡΜΑΚΟΤΕXΝΙΚΗ ΜΟΡΦΗ

Αναβράζοντα δισκία

Πόσιμο διάλυμα 

4. ΚΛΙΝΙΚΑ ΣΤΟΙΧΕΙΑ 

4.1.  ΘΕΡΑΠΕΥΤΙΚΈΣ ΕΝΔΕΊΞΕΙΣ

Σε ενήλικες ενδείκνυται ως βλεννολυτικό για τη συμπτωματική αντιμετώπιση του βήχα. 

Στα   παιδιά   από   τεσσάρων   ετών   και   πάνω,   ενδείκνυται   η   χρήση   του   πόσιμου   διαλύματος   ως 

βλεννολυτικό για τη συμπτωματική  αντιμετώπιση του βήχα. 

4.2  ΔΟΣΟΛΟΓΊΑ ΚΑΙ ΤΡΌΠΟΣ ΧΡΉΣΗΣ

Αναβράζοντα δισκία

Ενήλικες και άτομα ηλικίας άνω των 12 ετών

Συνίσταται η λήψη ενός αναβράζοντος δισκίου, 2 φορές την ημέρα. Τα δισκία πρέπει να λαμβάνονται 

αφού διαλυθούν σε ένα ποτήρι νερό 

Πόσιμο διάλυμα

Παιδιά από 4-5 ετών: 1,5 ml 3 φορές   την ημέρα.

Παιδιά από 6-12 ετών: 2,5 ml 3 φορές την ημέρα.  

Παιδιά από 12 ετών και ενήλικες: 5 ml 3 φορές την ημέρα

Η   διάρκεια   της   θεραπείας   εξαρτάται   από   τον   τύπο   και   τη   σοβαρότητα   των   συμπτωμάτων,   με 

χορήγηση τουλάχιστον μια εβδομάδα. (Σε περίπτωση που επιμένουν ή εμφανιστούν συμπτώματα 

Π ΕΡΊΛΗΨΗ  Τ ΩΝ  Χ ΑΡΑΚΤΗΡΙΣΤΙΚΏΝ  Τ ΟΥ  Π ΡΟΪΌΝΤΟΣ

όπως δυσκολία στην αναπνοή, πυρετός καθώς και πυώδεις ή αιματηρές αποχρέμψεις, συνιστάται να 

συμβουλευθείτε αμέσως το γιατρό σας).

  

4.3.  AΝΤΕΝΔΕΊΞΕΙΣ

Δυσανεξία στη φρουκτόζη.

Υπερευαισθησία στο δραστικό συστατικό ή σε φυτά της οικογένειας των Araliaceae.

4.4. ΙΔΙΑΊΤΕΡΕΣ ΠΡΟΕΙΔΟΠΟΙΉΣΕΙΣ ΚΑΙ ΠΡΟΦΥΛΆΞΕΙΣ ΚΑΤΆ ΤΗΝ ΧΡΉΣΗ

Σε μικρά παιδιά η υπέρβαση της δοσολογίας μπορεί να προκαλέσει ναυτία ή και εμετό.  

Σε περίπτωση που επιμένουν ή εμφανιστούν συμπτώματα όπως δυσκολία στην αναπνοή, πυρετός 

καθώς και πυώδεις ή αιματηρές αποχρέμψεις, συνιστάται να συμβουλευθείτε αμέσως το γιατρό σας.

Συνιστάται προσοχή σε ασθενείς με γαστρίτιδα ή γαστρικό έλκος.

Ταυτόχρονη   χορήγηση   με   αντιβηχικά  όπως  κωδεΐνη   ή  dextromethorphane  δεν  συνιστάται  χωρίς 

ιατρική συμβουλή. 

4.5.   ΑΛΛΗΛΕΠΙΔΡΆΣΕΙΣ ΜΕ ΆΛΛΑ ΦΆΡΜΑΚΑ ΚΑΙ ΆΛΛΕΣ ΜΟΡΦΈΣ ΑΛΛΗΛΕΠΙΔΡΆΣΗΣ 

Η μέχρι τώρα χρήση του PROSPAN δεν έχει δείξει τουλάχιστον κλινικά σημαντικές αλληλεπιδράσεις 

με   άλλα   φάρμακα.   Μαζί   με   αντιασθματικά   ή   βλεννολυτικά   έχει   αναφερθεί   μειωμένη   ανοχή   του 

φαρμάκου. Έχει χορηγηθεί μαζί με αντιβιοτικά χωρίς να παρατηρηθεί αλληλεπίδραση. Επειδή σε μια 

μελέτη το είδος  Hedera  helix  L.,  ssp.  Canariensis  (wild) έδειξε  in  vitro  σημαντική αντιθρομβωτική 

δράση, καλό είναι άτομα που λαμβάνουν κουμαρινικά αντιπηκτικά να το λαμβάνουν υπόψη, για την 

πιθανότητα συνεργικής δράσης, αν και δεν υπάρχουν μελέτες στον άνθρωπο, σχετικά με αυτή την 

πιθανή αλληλεπίδραση.  

4.6.  ΧΟΡΉΓΗΣΗ ΚΑΤΆ ΤΗΝ ΚΎΗΣΗ ΚΑΙ ΤΟΝ ΘΗΛΑΣΜΌ

Επειδή σε πειραματόζωα το φάρμακο προκάλεσε μια ανακατανομή του ψευδαργύρου και άλλων 

ιχνοστοιχείων, να μη χορηγείται στη κύηση και στη γαλουχία, αφού δεν υπάρχουν επαρκή δεδομένα 

στον άνθρωπο.  

4.7.  ΕΠΊΔΡΑΣΗ ΣΤΗΝ ΙΚΑΝΌΤΗΤΑ ΟΔΉΓΗΣΗΣ ΚΑΙ ΧΕΙΡΙΣΜΟΎ ΜΗΧΑΝΗΜΆΤΩΝ.

Δεν   έχουν   παρατηρηθεί   συμπτώματα   επίδρασης   στην   ικανότητα   του   ασθενούς   να   οδηγεί   ή   να 

χειρίζεται μηχανήματα κατά τη χορήγηση του PROSPAN. 

4.8.  ΑΝΕΠΙΘΎΜΗΤΕΣ ΕΝΈΡΓΕΙΕΣ

Συχνές: γαστρεντερικές διαταραχές (ναυτία, εμετός, διάρροια, μετεωρισμός)

Όχι συχνές: αλλεργικές αντιδράσεις (αλλεργικό εξάνθημα, κνίδωση, δύσπνοια)

           4.9.  ΥΠΕΡΔΟΣΟΛΟΓΊΑ

Υπερδοσολογία μπορεί να προκαλέσει ναυτία, έμετο, διάρροια.

Τηλ. Κέντρου Δηλητηριάσεων Αθηνών:  210 77.93.777

           5.  ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ

           5.1.  ΦΑΡΜΑΚΟΔΥΝΑΜΙΚΈΣ ΙΔΙΌΤΗΤΕΣ

Ο   μηχανισμός   δράσης   στον   οποίο   οφείλονται   οι   ανωτέρω   αναφερόμενες   ιδιότητες   του   ξηρού 

εκχυλίσματος   των   φύλλων   κισσού   (οι   οποίες   έχουν   μελετηθεί   σε   μελέτες   με   ζώα   και   έχουν 

αποδειχθεί κλινικά) δεν έχει μέχρι σήμερα πλήρως διευκρινιστεί. 

Η εκκριτική δράση του εκχυλίσματος οφείλεται κυρίως στην   σαπωνιδική φύση των τριτερπενικών 

γλυκοσιδών, ενώ η παρασυμπαθολυτική δράση ορισμένων γλυκοσιδών θεωρείται ότι είναι η βάση 

των σπασμολυτικών ιδιοτήτων, οι οποίες κυρίως ασκούνται επί των φλεγμονοδών βρόγχων.

Δεν υπάρχουν επαρκή στοιχεία για την επίδραση του φαρμάκου στο κέντρο του βήχα. Η μείωση των 

επεισοδίων βήχα οφείλεται στη διευκόλυνση της απόχρεμψης. 

6.  ΦΑΡΜΑΚΕΥΤΙΚΑ ΣΤΟΙΧΕΙΑ

6.1.  ΚΑΤΆΛΟΓΟΣ ΜΕ ΤΑ ΈΚΔΟΧΑ

Αναβράζοντα  δισκία: Citric acid anhydrous, sodium hydrogen carbonate, mannitol, simethicone, 

saccharin sodium, sodium cyclamate, sodium citrate, sorbitol, medium chain triglycerides, polyoxyl 

40 hydrogenated castor oil, aroma.

Πόσιμο διάλυμα: Sorbitol solution 70%, Cherry essence, Xanthan gum, Potassium sorbate, Citric 

acid anhydrous, Water purified.  

6.2.  ΑΣΥΜΒΑΤΌΤΗΤΕΣ 

Δεν είναι γνωστές μέχρι σήμερα. 

6.3.  ΔΙΆΡΚΕΙΑ ΖΩΉΣ

Αναβράζοντα δισκία: Η διάρκεια ζωής του προϊόντος είναι 24 μήνες. 

Πόσιμο διάλυμα: Η διάρκεια ζωής του προϊόντος είναι 36 μήνες. 

Δεν πρέπει να χρησιμοποιείται μετά την ημερομηνία λήξης. 

6.4.  ΙΔΙΑΊΤΕΡΕΣ ΠΡΟΦΥΛΆΞΕΙΣ ΚΑΤΆ ΤΗ ΦΥΛΑΞΗ ΤΟΥ ΠΡΟΪΌΝΤΟΣ 

Πρέπει να φυλάσσεται σε θερμοκρασία μέχρι 25ºC.

6.5.  ΦΎΣΗ ΚΑΙ ΣΥΣΤΑΤΙΚΆ ΤΟΥ ΠΕΡΙΈΚΤΗ

Αναβράζοντα   δισκία:  Κουτί   που   περιέχει   20   αναβράζοντα   δισκία   των   65  mg/δισκίο   σε  strips 

αλουμινίου. 

Πόσιμο διάλυμα: Γυάλινο  φιαλίδιο των 100ml (Fl x 100 ml).

6.6.  ΟΔΗΓΊΕΣ ΧΡΗΣΗΣ/ΧΕΙΡΙΣΜΟΥ

Αναβράζοντα δισκία: Τα δισκία διαλύονται σε ένα ποτήρι νερό (200 ml). Μπορεί να χρησιμοποιηθεί 

ζεστό ή κρύο νερό.

Πόσιμο διάλυμα: Δεν απαιτούνται ιδιαίτερες οδηγίες χρήσης. 

6.7. ΚΑΤΟΧΟΣ ΤΗΣ ΆΔΕΙΑΣ ΚΥΚΛΟΦΟΡΊΑΣ  

ΦΑΡΜΑΣΥΝ Α.Ε., Μονής Δαμάστας 6 Περιστέρι 121 33, 

Τηλ.: 210-5777140, Fax: 210-5788791

7.   ΑΡΙΘΜΟΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ 

            

            PROSPAN, Πόσιμο διάλυμα 35 mg/ 5 ml 43842/07/29-10-2008

            PROSPAN, Αναβράζοντα δισκία 65 mg/tab 84498/26-11-2009

8.   ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ / ΑΝΑΝΕΩΣΗΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

            

            PROSPAN, Πόσιμο διάλυμα 35 mg/ 5 ml 6-9-2002/29-10-2008

            PROSPAN, Αναβράζοντα δισκία 65 mg/tab 6-9-2002/29-10-2008

9.  ΗΜΕΡΟΜΗΝΙΑ (ΜΕΡΙΚΗΣ) ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ 

            PROSPAN, Πόσιμο διάλυμα 35 mg/ 5 ml 23761/11-4-2007

Document Outline

  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.

    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.



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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

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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

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

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.

Health Canada

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

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

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

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration