D-0729-2021 Class II Terminated

Recalled by Spirit Pharmaceuticals — Ronkonkoma, NY

FDA drug recall D-0729-2021 was initiated by Spirit Pharmaceuticals on June 16, 2021 and is designated Class II. Reason for recall: cGMP deviations: Discolored acetaminophen The recall status is terminated (terminated September 7, 2022). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
August 25, 2021
Initiation Date
June 16, 2021
Termination Date
September 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

Reason for Recall

cGMP deviations: Discolored acetaminophen

Distribution Pattern

USA Nationwide

Code Information

Lot #: S210240, Exp. 03/2023