Prescription Drugs

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

Failed Dissolution Specifications

Presence of Particulate Matter: Cardboard

Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

Presence of Particulate Matter: Glass particulate found in sterile injectable product

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.