PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Reported: December 4, 2013 Initiated: October 9, 2013 #D-018-2014

Product Description

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Reason for Recall

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Details

Recalling Firm
Actavis Elizabeth LLC
Units Affected
756 bottles
Distribution
Nationwide
Location
Elizabeth, NJ

Frequently Asked Questions

What product was recalled?
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11. Recalled by Actavis Elizabeth LLC. Units affected: 756 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
Which agency issued this recall?
This recall was issued by the FDA Drug on December 4, 2013. Severity: Moderate. Recall number: D-018-2014.