FDA Drug Recalls

Recalls / Class III

Class IIID-0273-2022

Product

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30

Affected lot / code info
Lot #: AC2103329C, Exp 1/2023

Why it was recalled

Failed dissolution specifications

Recalling firm

Firm
Dr. Reddy's Laboratories, Inc.
Notification channel
Letter
Type
N/A
Address
107 College Rd E, N/A, Princeton, New Jersey 08540-6623

Distribution

Quantity
N/A
Distribution pattern
USA Nationwide.

Timeline

Recall initiated
2021-11-12
FDA classified
2021-12-07
Posted by FDA
2021-12-15
Terminated
2023-06-23
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0273-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.