FDA Drug Class II — Moderate

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Hazard

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Products

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086
Brand
Actavis Elizabeth LLC
UPC
Lot #: 57617531, Exp 03/14

Units Affected

5,148 bottles