Drug product
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.
D-0197-2025
Product summary
- Event
- Event 95944
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 7198 bottles
- Official record key
drug-enforcement:D-0197-2025
Official wording
Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Code information: Lot: KDC0124001A Exp 09/30/2026.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.