D-0379-2022 Class III Terminated
FDA drug recall D-0379-2022 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: 2,352 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
- 2,352 boxes
Product Description
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: AC2106452F, 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-0379-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026