Drug product
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
D-0354-2023
Product summary
- Event
- Event 91717
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,392 bottles
- Official record key
drug-enforcement:D-0354-2023
Official wording
Reason: Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Code information: Lot # G177092, Exp. 11/24
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets