Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Preferred Pharmaceuticals
cGMP Deviations
💊 Drugs • 12,141 recalls
Preferred Pharmaceuticals
cGMP Deviations
Subpotent
Mckesson Medical-Surgical Inc. Corporate Office
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Subpotent
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP deviations
cGMP deviations
Breckenridge Pharmaceutical
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of Assurance of Sterility: Leaking/damaged syringes.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
Denver Solutions, LLC
Lack of Assurance of Sterility: Leaking/damaged syringes.
cGMP deviations
CGMP Deviations