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Showing 6101–6120 of 15081 results

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Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.

Class IIModerate

FDAMar 1, 2019AZ, IN, TN• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Drospirenone Ethinyl Estradiol Tablets (Apotex) – Tablet Sequence Error (2019)

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Class IIModerate

FDAMar 1, 2019Nationwide• Apotex Inc.

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Hydrochlorothiazide Tablets (Torrent) – Impurity Risk (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

MycoBotanicals Blood Sugar (Fungi Perfecti) – undeclared wheat (2019)

Undeclared Gluten

Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat.

Class IIModerate

FDAFeb 28, 2019Nationwide• Fungi Perfecti LLC

Losartan Potassium Tablets (Torrent Pharma) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Losartan Hydrochlorothiazide Tablets (Torrent) – Impurity Risk (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Torrent) – Impurity Risk (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Class IIModerate

FDAFeb 28, 2019Nationwide• Torrent Pharma Inc.

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Numb 100 Topical Anesthetic (Clinical Resolution) – safety closure (2019)

This recall involves Numb 100 Topical Anesthetic Cream. The recalled cream is in a 1.35 fluid ounce white jar with a rounded cap. Numb 100 Topical Anesthetic Cream and a blue cross are printed on the jar's front panel.

CPSCFeb 28, 2019Nationwide• Clinical Resolution Laboratory, Inc. of Brea, Calif.

EZY Gel Topical Anesthetic (Biotouch) – safety closure (2019)

This recall involves EZY Gel Topical Anesthetic Gel. The recalled product was sold in 1 fluid ounce white bottles. Biotouch Topical Anesthetic Gel EZY Gel is printed on a purple label located on the front panel. Lot numbers and expiration dates are located on the bottom of the bottle.

CPSCFeb 28, 2019Nationwide• Biotouch Inc., of City of Industry, Calif.

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Bupropion Extended-Release Tablets (Jubilant) – Dissolution Failure (2019)

Failed Dissolution Specifications; 9-monthstability timepoint

FDAFeb 28, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Moxifloxacin Ophthalmic Solution (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

FDAFeb 26, 2019Nationwide• Lupin Pharmaceuticals Inc.

Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class IIModerate

FDAFeb 25, 2019Nationwide• Macleods Pharma Usa Inc

Telmisartan Hydrochlorothiazide Tablets (Macleods) – Blend Uniformity Issue (2019)

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Class IIModerate

FDAFeb 25, 2019Nationwide• Macleods Pharma Usa Inc

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