Drug Enforcement D-0195-2025

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

Status

Ongoing

Classification

Class III

Report Date

January 22, 2025

Termination Date

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Product Information

Product description
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
Product quantity
14825 bottles
Reason for recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall initiation reason
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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-0195-2025
Event ID
95944
Recall initiation date
December 12, 2024
Center classification date
January 10, 2025
Code info
Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026
More code info
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