D-0508-2025 Class II Ongoing
FDA drug recall D-0508-2025 was initiated by The Harvard Drug Group LLC on June 19, 2025 and is designated Class II. Reason for recall: Defective container; blister packaging inadequately sealed. The recall status is ongoing. Affected quantity: 3,527 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,527 bags
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
Reason for Recall
Defective container; blister packaging inadequately sealed.
Distribution Pattern
Nationwide
Code Information
Lot# M05205A and M05205B, Exp Date 10/2026.