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Recall D-0199-2025

Description: 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.

Recall D-0199-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0199-2025
Event ID95944
DistributionNationwide in the US
Quantity324 bottles
Recall ReasonLabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Drug ClassificationClass III
Drug Code Info20250122
Recall Initiation Date20241212
Report Date20250122
Classification Date20250110
Address373 Us Highway 46 Ste 117
Fairfield, NJ 07004-2456
United States
Recalling FirmAkron Pharma, Inc.
Initial Notification Letter
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