Drug Enforcement D-0507-2025

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, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Product quantity
23,232 cartons
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-0507-2025
Event ID
97087
Recall initiation date
June 19, 2025
Center classification date
July 3, 2025
Code info
Lot# M05205, Exp Date 10/2026
More code info
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