Recalls / Class III
Class IIID-0386-2022
Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
- Affected lot / code info
- Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 10,536 boxes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-01-04
- FDA classified
- 2022-01-18
- Posted by FDA
- 2022-01-26
- Terminated
- 2023-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.