Drug Enforcement D-0508-2025

Defective container; blister packaging inadequately sealed.

Status

Ongoing

Classification

Class II

Report Date

July 9, 2025

Termination Date

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Product Information

Product description
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Product quantity
3,527 bags
Reason for recall
Defective container; blister packaging inadequately sealed.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
The Harvard Drug Group LLC
Address
7000 Cardinal Pl

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0508-2025
Event ID
97087
Recall initiation date
June 19, 2025
Center classification date
July 3, 2025
Code info
Lot# M05205A and M05205B, Exp Date 10/2026.
More code info
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