Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Recalls of antibiotics used to treat bacterial infections.
197 recalls in this category, newest first.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Subpotent drug; Clavulanate Potassium component
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Temperature Abuse
CGMP Deviations; particulates identified during visual inspection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
cGMP Deviations
CGMP Deviations
CGMP Deviations
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
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
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
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.
Subpotent Drug
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
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