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Showing 4521–4540 of 14370 results

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Testosterone Cypionate/Progesterone Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Calcium Chloride Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Biotin Injectable Suspension (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Dexpanthenol Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

MIC-PLUS Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Hydroxyprogesterone Caproate Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lysine Hydrochloride Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Mitomycin-C Irrigation Solution (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Magnesium Chloride Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Testosterone Cypionate Injection (Sun Pharmaceutical) – Manufacturing Deviation (2020)

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Class IIModerate

FDAJan 14, 2020Nationwide• Sun Pharmaceutical Industries, Inc.

Ranitidine Hydrochloride Powder (Spectrum) – NDMA Impurity (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 14, 2020AZ, CA, FL +9 more• Spectrum Laboratory Products

Methylprednisolone Sodium Succinate Injection (Hikma) – Incorrect Labeling (2020)

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

FDAJan 14, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Nystatin Oral Suspension (Pharmaceutical Associates) – Subpotent Medication (2020)

Subpotent: Out of specification for assay at the 12-month time point.

Class IIModerate

FDAJan 14, 2020Nationwide• Pharmaceutical Associates Inc

Testosterone Cypionate Injection (Sun Pharmaceutical) – Manufacturing Deviation (2020)

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Class IIModerate

FDAJan 14, 2020Nationwide• Sun Pharmaceutical Industries, Inc.

Tri-Lo-Marzia (Lupin Pharmaceuticals) – CGMP Test Deviation (2020)

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

FDAJan 10, 2020Nationwide• Lupin Pharmaceuticals Inc.

Estriol USP Micronized (Letco Medical) – Subpotent (2020)

Subpotent

Class IIModerate

FDAJan 10, 2020Nationwide• Letco Medical LLC

NETSPOT (Advanced Accelerator Applications) – Defective Container Cap (2020)

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Class IIModerate

FDAJan 10, 2020Nationwide• Advanced Accelerator Applications USA, Inc.

Ranitidine Hydrochloride (PD-Rx Pharmaceuticals) – NDMA Contamination (2020)

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Class IIModerate

FDAJan 10, 2020AZ, CA, FL +9 more• PD-Rx Pharmaceuticals, Inc.

Joint Health Movement Supplement (Merical) – missing shellfish warning (2020)

Product label does not contain Crustacean Shellfish on the ingredient list or allergen information

Class IIModerate

FDAJan 9, 2020IN, MI• Merical, LLC

Nizatidine Capsules (Mylan) – NDMA Impurity (2020)

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Class IIModerate

FDAJan 7, 2020Nationwide• Mylan Pharmaceuticals Inc.

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