CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals…
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Recalls of antibiotics used to treat bacterial infections.
192 recalls in this category, newest first.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Reason Subpotent drug; Clavulanate Potassium component
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Temperature Abuse
Reason CGMP Deviations; particulates identified during visual inspection
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20…
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Reason CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Reason cGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Subpotent Drug
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle…
Reason Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of…
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle…
Reason Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle…
Reason Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of…
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
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