Drugs Recalls

GMP Deviations: potential glass contamination

Lack of sterility assurance.

Presence of Foreign Substance; Fiber particles.

Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.

Crystallization: Presence of particulate matter identified as API crystallization

Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.

Superpotent

CGMP Deviations: Received notice from supplier that there is potential glass contamination.

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Lack of Assurance of Sterility: Bag has the potential to leak.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Microbial Contamination of Non-Sterile Product.

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.

Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

GMP Deviation: lot not intended for commercial distribution.

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.