Drug product
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.
D-0382-2022
Product summary
- Event
- Event 89364
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,912 boxes
- Official record key
drug-enforcement:D-0382-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications