Prescription and over-the-counter medications
Teva Pharmaceuticals USA
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Presence of Particulate Matter
Subpotent Drug
IntegraDose Compounding Services
Lack of Assurance of Sterility: leaking bags
Lack of Assurance of Sterility: Firm did not perform process validation.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
B. Braun Medical
Lack of assurance of sterility: bags have the potential to leak..
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Lack of Assurance of Sterility: Firm did not perform process validation.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Lack of Assurance of Sterility
SCA Pharmaceuticals
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of Particulate Matter.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Apothecus Pharmaceutical
cGMP Diviations