Recalls / Class III
Class IIID-0379-2022
Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
- Affected lot / code info
- Lot #: AC2106452F, 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
- 2,352 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-0379-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.