Drug product
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
D-0539-2023
Product summary
- Event
- Event 91918
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 135 bottles
- Official record key
drug-enforcement:D-0539-2023
Official wording
Reason: Out of specification (OOS) for Spectroscopic Identification test by IR.
Code information: Lot #22143120, Exp. Date: June 2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification