D-0269-2022 Class III Terminated
FDA drug recall D-0269-2022 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: 5016 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
- 5016 cartons
Product Description
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
Reason for Recall
Failed dissolution specifications
Distribution Pattern
USA Nationwide.
Code Information
Lot #: AC2103329F, Exp 1/2023