Drug product
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
D-1272-2020
Product summary
- Event
- Event 85646
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,202 bottles
- Official record key
drug-enforcement:D-1272-2020
Official wording
Reason: Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Code information: Lot # NB900413, Exp. 12/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications