Prescription Drugs

Lack of Assurance of Sterility.

Subpotent Drug

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Failed Dissolution Specifications: Low out of specification results for dissolution.

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.

Failed Impurities/Degradation Specifications.

Failed Impurities/Degradation Specifications.

CGMP Deviations: Firm failed to control impurity for color change at the API stage.

Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.

Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.

Failed Dissolution Specifications