Recalls / Class II
Class IID-0342-2022
Product
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
- Affected lot / code info
- Lot 0GR0445, Exp 1/31/2022; 0LR0361, Exp 4/30/2022; 1AR0558, Exp 7/31/2022
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recalling firm
- Firm
- Perrigo Company PLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 65,796 containers
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-07-27
- FDA classified
- 2022-01-05
- Posted by FDA
- 2022-01-12
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0342-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.