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.
FDA recall notice · announced March 12, 2014 · Actavis Elizabeth
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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.
Reason for recall
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Notes
Distribution: Nationwide
Lot/code information: Lot #: 57617531, Exp 03/14
Quantity: 5,148 bottles
Status: Terminated
Products in this recall event:
- 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- (D-1091-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.