D-0382-2022 Class III Terminated
FDA drug recall D-0382-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 4, 2022 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Oct 20, 2023). Affected quantity: 9,912 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 26, 2022
- Initiation Date
- Jan 4, 2022
- Termination Date
- Oct 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,912 boxes
Product Description
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 for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0382-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026