Recalls / Class III
Class IIID-0274-2022
Product
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
- Affected lot / code info
- Lot #: AC2103329B
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
- 9,984 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-0274-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.