D-0274-2022 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

FDA drug recall D-0274-2022 was initiated by Dr. Reddy's Laboratories, Inc. on November 12, 2021 and is designated Class III. Reason for recall: Failed dissolution specifications The recall status is terminated (terminated June 23, 2023). Affected quantity: 9,984 cartons.

Recall Details

Product Type
Drugs
Report Date
December 15, 2021
Initiation Date
November 12, 2021
Termination Date
June 23, 2023
Voluntary/Mandated
N/A
Product Quantity
9,984 cartons

Product Description

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.

Reason for Recall

Failed dissolution specifications

Distribution Pattern

USA Nationwide.

Code Information

Lot #: AC2103329B