Drug product
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
D-0570-2023
Product summary
- Event
- Event 92174
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3984 cartons
- Official record key
drug-enforcement:D-0570-2023
Official wording
Reason: Product mixup: one foreign tablet found in product.
Code information: Lot: T04468, Exp 10/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet