Recalls / Class III
Class IIID-0268-2022
Product
Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
- Affected lot / code info
- Lot #: AC2103329I, 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
- 14976 cartons
- 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-0268-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.