Prescription Drugs

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Failed Dissolution Specifications

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.