Drugs Recalls

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil

Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Lack of Assurance of Sterility.

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

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

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.

Lack of Assurance of Sterility.

Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

CGMP Deviations