Recalls / Class III
Class IIID-0275-2022
Product
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
- Brand name
- Fexofenadine Hcl And Pseudoephedrine Hci
- Generic name
- Fexofenadine Hcl And Pseudoephedrine Hci
- Active ingredients
- Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride
- Route
- Oral
- NDC
- 43598-823
- FDA application
- ANDA076667
- Affected lot / code info
- Lot #: AC2103329A
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- 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
- 2,928 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-0275-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.