FDARecalled Oct 29, 2025 · #D-0031-2026
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 5...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Classification: Class II Distribution: US Nationwide.
Product details
- Product
- 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).
- Type
- Drugs
- Manufacturer
- The Harvard Drug Group LLC
- Model numbers
- M04989A, M05056A, M05150A, M05312A
- UPCs
- —