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Showing 5481–5500 of 14454 results

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Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Sub Potent Drug (2019)

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

Class IIModerate

FDAMar 12, 2019Nationwide• Akorn Inc

Volumex Injection (Iso-Tex) – Sterility Risk (2019)

Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Class IIModerate

FDAMar 11, 2019TN• Iso-Tex Diagnostics, Inc

Lansoprazole Orally Disintegrating Tablets (Teva) – Subpotent Drug (2019)

Subpotent Drug.

FDAMar 11, 2019Nationwide• Teva Pharmaceuticals USA

Losartan Potassium Tablets (PD-Rx) – CGMP Impurity (2019)

CGMP deviation: Product found to contain trace amounts of NMBA

Class IIModerate

FDAMar 8, 2019AK, AZ, CA +11 more• PD-Rx Pharmaceuticals, Inc.

Mirapex Tablets (Boehringer) – Weight Specification Failure (2019)

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

FDAMar 7, 2019Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

Valsartan 160mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Little Remedies Baby Kit (Medtech) – Labeling Error (2019)

Undeclared Allergen

Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.

Class IIModerate

FDAMar 7, 2019Nationwide• Medtech Products, Inc.

Valsartan 80mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Losartan Potassium Tablets (Preferred) – CGMP Impurity (2019)

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

Class IIModerate

FDAMar 6, 2019CA, GA, IN• Preferred Pharmaceuticals, Inc

Docetaxel Injection (Dr. Reddy's) – Container Defect (2019)

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

Class IIModerate

FDAMar 6, 2019Nationwide• Dr. Reddy's Laboratories, Inc.

Valsartan Tablets 160mg (American Health) – CGMP Impurity (2019)

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Class IIModerate

FDAMar 6, 2019Nationwide• American Health Packaging

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

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

Class IIModerate

FDAMar 5, 2019Nationwide• AVKARE Inc.

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

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

Class IIModerate

FDAMar 5, 2019Nationwide• AVKARE Inc.

Losartan Hydrochlorothiazide Tablets (AVKARE) – CGMP Impurity (2019)

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

Class IIModerate

FDAMar 5, 2019Nationwide• AVKARE Inc.

Losartan Potassium Tablets (Pharma Pac) – Impurity Detection (2019)

CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).

Class IIModerate

FDAMar 4, 2019CA, IN• H J Harkins Company Inc dba Pharma Pac

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.

Aspirin Dipyridamole Capsules (American Health) – Impurity Specs (2019)

Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.

Class IIModerate

FDAMar 1, 2019Nationwide• American Health Packaging

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

Oxybutynin Chloride Tablets (AVKARE) – Dissolution Failure (2019)

Failed Dissolution Specifications

FDAMar 1, 2019Nationwide• AVKARE Inc.

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