Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.
Reason
Failed Dissolution Specifications
Classification
Class III
Status
Terminated
Lot
Lot #s: a) (10-count): AC2103328D, Exp. 1/31/2023. b) (20-count) :AC2000968C, Exp. 8/31/2022. c) (30-count): AC2103330C, Exp. 1/31/2023; AC2106452D, Exp. 3/31/2023.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.