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The Harvard Drug Group LLC: Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapol

DrugsSource: FDA (drug) · Date: 2025-10-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
The Harvard Drug Group LLC
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).
Reason / hazard
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-10-10
Code info
Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
Voluntary mandated
Voluntary: Firm initiated
City
Dublin
State
OH
Country
United States
Event id
97777
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