FDAFDA · Food and drugs·Recall number D-0342-2022
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
Published January 12, 2022 · Recall initiated: July 27, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Perrigo Company PLC
- Distributor
- Nationwide in the USA
- Lot
- Lot 0GR0445, Exp 1/31/2022; 0LR0361, Exp 4/30/2022; 1AR0558, Exp 7/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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