Recalls / Class III
Class IIID-0271-2022
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
- Affected lot / code info
- Lot #: AC2103329D, Exp 1/2023
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
- 2184 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-0271-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.