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Recall Observatory FDA recall evidence

Drug product

Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

D-0507-2025

June 19, 2025

Class II

Product summary

Firm
The Harvard Drug Group LLC
Event
Event 97087
Status
Ongoing
Classification
Class II
Quantity
23,232 cartons
Official record key
drug-enforcement:D-0507-2025

Official wording

Reason: Defective container; blister packaging inadequately sealed.

Code information: Lot# M05205, Exp Date 10/2026

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container; blister packaging inadequately sealed.