Drug product
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
D-0287-2019
Product summary
- Event
- Event 81568
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0287-2019
Official wording
Reason: Presence of Foreign Substance; metal shard found in tablet
Code information: Lot 7143908, exp Nov 2020
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance