Recalls / Class III
Class IIID-0267-2022
Product
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.
- Brand name
- Allergy And Congestion
- Generic name
- Fexofenadine Hcl And Pseudoephedrine Hci
- Active ingredients
- Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride
- Route
- Oral
- NDC
- 11822-7388
- FDA application
- ANDA076667
- Affected lot / code info
- Lot #: AC2103329E, Exp 1/2023
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Rite Aid Corporation
- Notification channel
- Letter
- Type
- N/A
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4896 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-0267-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.