Prescription Drugs

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia

Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.

Non-Sterility; microbial contamination identified as Bacillus circulans

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Non-Sterility: failed sterility test result.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.