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Showing 4221–4240 of 14370 results

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Metformin Extended Release (Preferred Pharmaceuticals) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDAJun 17, 2020FL, IN• Preferred Pharmaceuticals, Inc.

Famotidine Injection (HF Acquisition) – Temperature Abuse (2020)

TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

FDAJun 17, 2020CT, IN• HF Acquisition Co. LLC

Heparin Sodium (SCA Pharmaceuticals) – Subpotent Medication (2020)

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Class IIModerate

FDAJun 16, 2020CA, IN, PA• SCA Pharmaceuticals

Metformin Extended Release (Harvard Drug) – NDMA Impurity (2020)

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

Class IIModerate

FDAJun 12, 2020Nationwide• The Harvard Drug Group

Clozapine Tablets (Aurobindo Pharma) – Tablet Mix-up (2020)

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Class IIModerate

FDAJun 12, 2020Nationwide• Aurobindo Pharma USA Inc.

Metformin Extended Release (Lupin Pharmaceuticals) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 11, 2020Nationwide• Lupin Pharmaceuticals Inc.

Irinotecan Injection (Hikma Pharmaceuticals) – Crimp Defect (2020)

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Class IIModerate

FDAJun 11, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Irinotecan Injection (Hikma Pharmaceuticals) – Crimp Defect (2020)

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Class IIModerate

FDAJun 11, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Anti-Viral Immune Enhance (Golden Nutrition) – Unauthorized Claims (2020)

The product is a dietary supplement with drug claims (COVID-19)

Class IIModerate

FDAJun 11, 2020Nationwide• GOLDEN NUTRITION INC

Nystatin Cream (Crown Laboratories) – Subpotent Medication (2020)

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Class IIModerate

FDAJun 10, 2020Nationwide• Crown Laboratories

Nabumetone Tablets (American Health Packaging) – Incomplete Labeling (2020)

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

FDAJun 10, 2020Nationwide• American Health Packaging

Aripiprazole Tablets (Alembic Pharmaceuticals) – Labeling Mixup (2020)

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

Class IIModerate

FDAJun 10, 2020Nationwide• Alembic Pharmaceuticals Limited

Nystatin Cream (Crown Laboratories) – Subpotent Medication (2020)

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

Class IIModerate

FDAJun 10, 2020Nationwide• Crown Laboratories

Minoxidil Capsules (MasterPharm) – Superpotent Medication (2020)

Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.

FDAJun 9, 2020FL, MD• MasterPharm LLC

Metformin HCL Extended-Release (PD-Rx) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 5, 2020Nationwide• PD-Rx Pharmaceuticals, Inc.

Prednisolone Sodium Phosphate (Akorn) – Discoloration Issue (2020)

Discoloration: Out of Specification (OOS) result for APHA Color Test.

FDAJun 5, 2020Nationwide• Akorn, Inc.

Metformin Hydrochloride Extended-Release (Marksans) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 5, 2020Nationwide• Marksans Pharma Limited

Metformin HCL Extended-Release (PD-Rx) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 5, 2020Nationwide• PD-Rx Pharmaceuticals, Inc.

Metformin Hydrochloride Extended-Release (AVKARE) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 4, 2020Nationwide• AVKARE Inc.

Metformin Hydrochloride Extended-Release (AVKARE) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 4, 2020Nationwide• AVKARE Inc.

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