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ClomiPRAMINE Hydrochloride Capsules (Leading Pharma) – Superpotent Drug (2022)

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

FDAAug 23, 2022Nationwide• Leading Pharma, LLC

Neomycin Sulfate Tablets (Teva) – CGMP Deviations (2022)

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

Class IIModerate

FDAAug 23, 2022Nationwide• Teva Pharmaceuticals USA Inc

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ClomiPRAMINE Hydrochloride Capsules (Leading Pharma) – Superpotent Drug (2022)

Neomycin Sulfate Tablets (Teva) – CGMP Deviations (2022)

Difluprednate Ophthalmic Emulsion (CIPLA) – Sterility Risk (2022)

Difluprednate Ophthalmic Emulsion (CIPLA) – Sterility Risk (2022)

Propofol Injectable Emulsion (Pfizer) – Particulate Matter (2022)

Triamcinolone Acetonide Cream (Padagis) – Texture Defect (2022)

Neostigmine Injection (Nephron) – Manufacturing Contamination (2022)

Ketorolac Injection (Nephron) – Cross-Contamination Risk (2022)

Bupivacaine HCl Injection (Nephron) – Manufacturing Contamination (2022)

Trisodium Citrate Solution (Nephron) – Manufacturing Contamination (2022)

Labetalol HCl Injection (Nephron) – Manufacturing Contamination (2022)

Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Acetaminophen 325 mg Tablets (Akron Pharma) – Missing Imprint (2022)

Acetaminophen Injection (Baxter Healthcare) – Temperature Abuse (2022)

Acetaminophen 500 mg Extra Strength (Akron Pharma) – Missing Imprint (2022)

Vitamin Herb Blend (Eclectic Institute) – Ingredient Mislabeling (2022)

Zynrelef (Heron Therapeutics) – Defective Syringe (2022)

PrednisoLONE Oral Solution (Akorn) – Incomplete Seals (2022)

Rifampin Capsules (Lupin) – Impurity Detected (2022)

Divalproex Sodium Tablets (Amneal) – Dissolution Failure (2022)