Recalls of antibiotics used to treat bacterial infections.
197 recalls in this category, newest first.
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 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
cGMP Deviations: Products were stored outside the drug label specifications.
Defective Container: slow leakage under the cap
Lack of sterility assurance
Lack of sterility assurance
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
CGMP Deviations:
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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