Prescription Drugs

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

Lack of sterility assurance.

Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.

Lack of sterility assurance.

Lack of sterility assurance.

Defective Container: Tamper Evident foil seal not completely intact.

Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Lack of sterility assurance.