D-0271-2022 Class III Terminated
FDA drug recall D-0271-2022 was initiated by Dr. Reddy's Laboratories, Inc. on November 12, 2021 and is designated Class III. Reason for recall: Failed dissolution specifications The recall status is terminated (terminated June 23, 2023). Affected quantity: 2184 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- December 15, 2021
- Initiation Date
- November 12, 2021
- Termination Date
- June 23, 2023
- Voluntary/Mandated
- N/A
- Product Quantity
- 2184 cartons
Product Description
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
Reason for Recall
Failed dissolution specifications
Distribution Pattern
USA Nationwide.
Code Information
Lot #: AC2103329D, Exp 1/2023