D-0193-2025 Class III Ongoing

Recalled by Akron Pharma, Inc. — Fairfield, NJ

FDA drug recall D-0193-2025 was initiated by Akron Pharma, Inc. on December 12, 2024 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. The recall status is ongoing. Affected quantity: 768 bottles.

Recall Details

Product Type
Drugs
Report Date
January 22, 2025
Initiation Date
December 12, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
768 bottles

Product Description

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

Reason for Recall

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

Distribution Pattern

Nationwide in the US

Code Information

Lot: KDT0224002A, Exp 09/30/2026