Drug Enforcement D-0194-2025

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 Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
Product quantity
6429 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-0194-2025
Event ID
95944
Recall initiation date
December 12, 2024
Center classification date
January 10, 2025
Code info
Lot #: KDT0124001, Exp 08/31/2026
More code info
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