D-0384-2022 Class III Terminated
FDA drug recall D-0384-2022 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: 9,984 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
- 9,984 boxes
Product Description
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: 79C002624D; 79C002625C, Exp. 4/30/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0384-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026