Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen…
Reason Presence of Particulate Matter: Presence of glass particulates.
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Reason Presence of Particulate Matter: Presence of glass particulates.
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason cGMP violations
Reason CGMP violations
Reason Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium…
Reason Presence of Particulate Matter: Presence of glass particle.
Reason Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Reason cGMP Deviations: Temperature excursion
Reason Lack of Assurance of Sterility
Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Reason LABELING: LABEL MIX-UP.
Reason Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone…
Reason Lack of Assurance of Sterility
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Reason Label mix-up: Carton incorrectly labeled.
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…
Reason Failed Dissolution Specifications