Drug product
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
D-0013-2018
Product summary
- Event
- Event 78162
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,935 cartons
- Official record key
drug-enforcement:D-0013-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Code information: Lot 1274C151A, Exp 10/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out-of-specification