KAY ESPRESSO MACHINE TABLET

Informasi Utama

  • Nama dagang:
  • KAY ESPRESSO MACHINE TABLET
  • Digunakan untuk:
  • manusia
  • Jenis Obat:
  • Perangkat medis

Dokumen

  • untuk masyarakat umum:
  • Informasi leaflet untuk produk ini saat ini tidak tersedia, Anda dapat mengirim permintaan untuk layanan pelanggan kami dan kami akan memberitahu Anda segera setelah kami mampu mendapatkannya.


    Meminta selebaran informasi untuk masyarakat umum.

Lokalisasi

  • Tersedia di:
  • KAY ESPRESSO MACHINE TABLET
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 908945-05
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

Lembar Data Keamanan Bahan

KAY ESPRESSO MACHINE

TABLET

1.

Identifikasi produk dan perusahaan

Nama dagang produk

1 /5

Penggunaan produk

: KAY ESPRESSO MACHINE TABLET

: Produk pembersih

Informasi pelarutan produk :

0.1%

Informasi pemasok

:

PT. ECOLAB INDONESIA

Mid Plaza II, Lantai 7

Jl. Jend. Sudirman Kav. 10-11

Jakarta 10220

Indonesia

Kode

Tanggal terbit

: 908945-05

: 13-October-2011

INFORMASI KESEHATAN DARURAT: 007-803-011-0364

2.

Identifikasi bahaya

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Wujud zat

Tinjauan

darurat

: Tablet

: PERHATIAN !

DAPAT MENYEBABKAN IRITASI MATA.

Hindari kontak dengan mata. Cuci

bersih-bersih setelah menangani bahan.

Cairan.

PERHATIAN!

Tidak ada bahaya

yang spesifik. Tidak

ada bahaya yang

spesifik.

Kemungkinan efek kesehatan akut

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Mata Kulit

Terhirup

Tertelan

: Iritasi sedang pada mata.

: Tidak ada efek yang signifikan atau bahaya

kritis yang diketahui.

: Tidak ada efek yang signifikan atau bahaya

kritis yang diketahui.

: Tidak ada efek yang signifikan atau bahaya

kritis yang diketahui.

Tak ada efek signifikan atau bahaya

kritis yang diketahui.

Tak ada efek signifikan atau bahaya

kritis yang diketahui.

Tak ada efek signifikan atau bahaya

kritis yang diketahui.

Tak ada efek signifikan atau bahaya

kritis yang diketahui.

Lihat informasi toksikologi (bagian 11)

3.

Komposisi / informasi kandungan

Amerika Serikat

Produk PADA SAAT DIJUAL

Nama

Nomor CAS

% berat

NATRIUM KARBONAT

497-19-8

20 - 50

NATRIUM KARBONAT PEROKSIDA

15630-89-4

20 - 50

ASAM SITRAT

77-92-9

20 -

polipropilen glikol 4000

25322-69-4

1 - 5

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Sejauh yang saat ini diketahui oleh pemasok, produk ini tidak mengandung bahan berbahaya dalam

jumlah yang perlu dilaporkan, sesuai dengan peraturan setempat.

KAY ESPRESSO MACHINE TABLET

13 Oktober 2011

4.

Tindakan pertolongan pertama

Produk PADA SAAT DIJUAL

Terkena mata

:

Jika terkena, segera basuh mata dengan air

yang banyak. Lepaskan lensa kontak dan basuh lagi.

Cari bantuan dokter jika iritasi terus berlangsung.

Kontak dengan kulit

:

Tidak ada efek pada mata yang diketahui setelah

kontak dengan kulit. Basuh dengan air selama

beberapa menit.

Terhirup

:

Tidak diperlukan tindakan khusus.

Lakukan perawatan sesuai gejala.

Tertelan

: Cari pertolongan medis jika muncul gejala.

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Tidak ada efek pada mata yang diketahui setelah

kontak dengan mata. Basuh dengan air selama

beberapa menit.

Tidak ada efek pada mata yang diketahui setelah

kontak dengan kulit. Basuh dengan air selama

beberapa menit.

Tidak diperlukan tindakan khusus.

Lakukan perawatan sesuai gejala.

Cari pertolongan medis jika muncul gejala.

5.

Tindakan pemadaman kebakaran

Produk PADA SAAT

DIJUAL

Produk penguraian

Produk dekomposisi dapat meliputi bahan-bahan berikut ini:

karbon dioksida

karbon monoksida

oksida logam

Media pemadam api dan

petunjuk

Perlengkapan pelindung khusus

untuk petugas pemadam

kebakaran

Gunakan bahan pemadam yang sesuai untuk api yang berkobar.

Buat batasan untuk area yang terbakar untuk mencegah api merambat.

Tak ada bahaya kebakaran atau ledakan spesifik.

Pemadam kebakaran harus mengenakan perlengkapan pelindung yang sesuai dan alat

bantu pernafasan lengkap (SCBA) yang menutupi seluruh wajah yang dioperasikan

dalam mode tekanan positif.

2 /5

6.

Tindakan pelepasan tak sengaja

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Pencegahan

diri

Pencegahan

lingkungan

Cara

membersihkan

Gunakan perlengkapan pelindung yang diperlukan.

Hindari kontak sejumlah besar tumpahan dan mengalirnya

bahan dengan tanah dan air.

Gunakan air untuk membilas pada pembersihan akhir.

Gunakan perlengkapan pelindung yang

diperlukan.

Hindari kontak sejumlah besar tumpahan dan

mengalirnya bahan dengan tanah dan air.

Gunakan air untuk membilas pada pembersihan akhir.

7.

Penanganan dan penyimpanan

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Penanganan

Penyimpanan

:

H i n d a r i

k o n t a k

d e n g a n

m a t a .

H i n d a r i

m e n g h i r u p

d e b u .

U s a h a k a n

k o n t a i n e r

t e r t u t u p

r a p a t .

H a n y a

gunakan di tempat yang

memiliki ventilasi baik. Cuci

bersih-bersih setelah menangani bahan.

: Jauhkan dari jangkauan anak-anak. Simpan di

dalam wadah tertutup.

Simpan di antara suhu berikut ini:

0 hingga 50°C

Cuci bersih-bersih setelah menangani bahan.

Simpan di luar jangkauan anak-anak.

8.

Kontrol paparan / perlindungan pribadi

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Tindakan

rekayasa

:

Ventilasi pada umumnya harus cukup baik untuk

mengontrol paparan pekerja terhadap kontaminan

di udara.

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap zat pengotor bawaan udara.

Perlindungan pribadi

Mata

:

Tidak diperlukan perlengkapan pelindung dalam kondisi

penggunaan normal.

Tidak diperlukan perlengkapan pelindung

dalam kondisi penggunaan normal.

KAY ESPRESSO MACHINE TABLET

13 Oktober 2011

8.

Kontrol paparan / perlindungan pribadi

Tangan

: Tidak diperlukan perlengkapan pelindung dalam kondisi

penggunaan normal.

Kulit

: Tidak diperlukan perlengkapan pelindung dalam kondisi

penggunaan normal.

Pernapasan

: Hindari menghirup debu.

Tidak diperlukan perlengkapan pelindung

dalam kondisi penggunaan normal.

Tidak diperlukan perlengkapan pelindung

dalam kondisi penggunaan normal.

Tidak diperlukan pelindung khusus.

Komposisi

Batas paparan

polipropilen glikol 4000

AIHA WEEL (Amerika Serikat, 5/2010).

TWA: 10 mg/m³ 8 jam. Bentuk: Aerosol

9.

Sifat fisika dan kimia

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Wujud zat

Tablet

Cairan.

Titik nyala

>

1 0 0 ° C

Produk tidak mendukung pembakaran.

> 100°C

Warna

Bau

pH

Kelarutan

:

H i j a u .

T a k

b e r b a u .

9 hingga 10 [Konsentrasi (% w/w): 1%]

Mudah larut di dalam bahan-bahan berikut ini: air dingin

dan air panas.

Bening

Tak berbau

10.

Stabilitas dan reaktivitas

Produk PADA SAAT

DIJUAL Stabilitas

Reaktivitas

Produk dekomposisi

berbahaya

:

Produk ini stabil. Pada kondisi penyimpanan dan penggunaan normal, polimerisasi

berbahaya tidak akan terjadi.

Sangat reaktif atau tidak kompatibel dengan bahan-bahan berikut ini: kelembapan.

Di bawah kondisi penyimpanan dan penggunaan normal, tidak akan dihasilkan produk

dekomposisi yang berbahaya.

Polimerisasi berbahaya

:

Pada kondisi penyimpanan dan penggunaan normal, polimerisasi berbahaya tidak akan terjadi.

11.

Informasi toksikologi

Kemungkinan efek kesehatan akut

Produk P

ADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Mata Kulit

Terhirup

Tertelan

Iritasi sedang pada mata.

Tidak ada efek yang signifikan atau bahaya kritis

yang diketahui.

Tidak ada efek yang signifikan atau bahaya kritis

yang diketahui.

Tidak ada efek yang signifikan atau bahaya kritis

yang diketahui.

Tak ada efek signifikan atau bahaya kritis

yang diketahui.

Tak ada efek signifikan atau bahaya kritis

yang diketahui.

Tak ada efek signifikan atau bahaya kritis

yang diketahui.

Tak ada efek signifikan atau bahaya kritis

yang diketahui.

12.

Informasi ekologi

Ekotoksisitas

:

Tidak dilaporkan

3 /5

4 /5

13 Oktobe

r 2011

KAY E

SPRESSO MACHINE TABLET

13

.

Pertimbangan pembuangan

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Pembuangan

limbah

Produk YANG DILARUTKAN SAAT PENGGUNAAN

dapat dibuang ke selokan pembuangan. Buang wadah

yang kosong ke tempat sampah.

Produk YANG DILARUTKAN SAAT

PENGGUNAAN dapat dibuang ke selokan

pembuangan.

Buang wadah yang

kosong ke tempat sampah.

14.

Informasi pengangkutan

Cara pengiriman atau ukuran kemasan tertentu mungkin memiliki pengecualian dari peraturan transportasi. Klasifikasi yang

tersedia mungkin tidak menunjukkan pengecualian tersebut dan mungkin tidak dapat diterapkan ke semua cara pengiriman

atau ukuran paket.

Produk PADA SAAT DIJUAL

Klasifikasi DOT

Tidak diatur.

Untuk pengangkutan dalam jumlah besar atau apabila menggunakan regulasi IMDG, baca dokumen pengiriman untuk

informasi pengangkutan khusus.

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Tidak ditujukan untuk transportasi.

15.

Informasi regulasi

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Amerika Serikat

Klasifikasi HCS

: Bahan yang menyebabkan iritasi

Tidak diatur.

16.

Informasi lainnya

Produk PADA SAAT DIJUAL

Produk YANG DILARUTKAN SAAT PENGGUNAAN

Bahan Berbahaya

:

Sistem Informasi (A.S.)

Kesehatan

Flamabilitas

Bahaya fisika

As

osiasi Perlindungan Kebakaran

Nasional (A.S.)

Kesehatan

Flamabilitas

1

0

Ketidakstabilan/

Reaktivitas

Khusus

Kesehatan

Flamabilitas

1

0

Ketidakstabilan/

Reaktivitas

Khusus

Tanggal terbit

:

13-October-2011

Nama penanggung jawab

:

Kantor Urusan Peraturan

1-800-352-5326

Menunjukkan informasi yang diubah dari versi terbitan sebelumnya.

Pemberitahuan bagi pembaca

Kesehatan

Flamabilitas

Bahaya fisika

5 /5

13 Oktobe

r 2011

KAY E

SPRESSO MACHINE TABLET

16.

Informasi lainnya

Informasi di atas diyakini benar dalam kaitannya dengan rumus yang digunakan untuk memproduksi produk ini di negara

asal. Karena data, standar, dan peraturan senantiasa berubah, dan kondisi penggunaan dan penanganan berada di luar kendali kami,

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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

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

5-11-2018

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

The side inter-lock button may stick when gripping the machine, which could cause the throttle trigger to remain depressed and the chain to continue to run even after releasing the throttle trigger. This can pose a risk of laceration to the user or bystander.

Health Canada

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

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

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-10-2018

Core Health & Fitness recalls Stairmaster 8G Gauntlet Stepmill Machines

Core Health & Fitness recalls Stairmaster 8G Gauntlet Stepmill Machines

The steps can accelerate rapidly without input from the user, posing a fall hazard.

Health Canada

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

21-8-2018

BMC USA Corp. recalls Timemachine 01 bicycles

BMC USA Corp. recalls Timemachine 01 bicycles

Variations in tire dimension, tire pressure, head set play and ride load, can result in insufficient space between the front wheel and downtube, posing a fall hazard.

Health Canada

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

28-6-2018

Need for Seal tablets

Need for Seal tablets

Need for Seal tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

Gold Maka tablets

Gold Maka tablets

Gold Maka tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

28-6-2018

One Night Lover tablets

One Night Lover tablets

One Night Lover tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets

Bulbao Male Enhancer tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

5-6-2018

Valpam 5 (diazepam) 5 mg tablets

Valpam 5 (diazepam) 5 mg tablets

Product defect alert - potential for blister strip to contain lower strength tablets

Therapeutic Goods Administration - Australia

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

21-10-2018

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9

FDA - U.S. Food and Drug Administration