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Recall Observatory FDA recall evidence

Drug product

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

D-0199-2025

December 12, 2024

Class III

Product summary

Firm
Akron Pharma, Inc.
Event
Event 95944
Status
Ongoing
Classification
Class III
Quantity
324 bottles
Official record key
drug-enforcement:D-0199-2025

Official wording

Reason: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Code information: Lot: KDC0224001B Exp 09/30/2026

Distribution pattern: Nationwide in the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.