Drug product
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
D-0030-2026
Product summary
- Event
- Event 97777
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0030-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Code information: Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification