FDA-Drug2025-10-29Class II
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
The Harvard Drug Group LLC
Hazard
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Sold states
US Nationwide.
Manufactured in
7000 Cardinal Pl, Dublin, OH, United States
Products
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2026Don't want to check this manually?
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