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
Reported: January 12, 2022 Initiated: July 27, 2021 #D-0342-2022
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Details
- Recalling Firm
- Perrigo Company PLC
- Units Affected
- 65,796 containers
- Distribution
- Nationwide in the USA
- Location
- Allegan, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Perrigo Company PLC. Units affected: 65,796 containers.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0342-2022.
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