Status
Ongoing
Drug Enforcement D-0197-2025
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Classification
Class III
Report Date
January 22, 2025
Termination Date
—
Product Information
- Product description
- Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
- Product quantity
- 7198 bottles
- Reason for recall
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Akron Pharma, Inc.
- Address
-
373 Us Highway 46 Ste 117
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0197-2025
- Event ID
- 95944
- Recall initiation date
- December 12, 2024
- Center classification date
- January 10, 2025
- Code info
- Lot: KDC0124001A Exp 09/30/2026.
- More code info
- —