D-018-2014 Class II Terminated
FDA drug recall D-018-2014 was initiated by Actavis Elizabeth LLC on October 9, 2013 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets The recall status is terminated (terminated November 3, 2014). Affected quantity: 756 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 4, 2013
- Initiation Date
- October 9, 2013
- Termination Date
- November 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756 bottles
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
Distribution Pattern
Nationwide
Code Information
Lot # 59380831, Exp. May 2014