MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg recall: Impurity Out of Spec
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
Why was MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg recalled?
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 0GR0445, Exp 1/31/2022; 0LR0361, Exp 4/30/2022; 1AR0558, Exp 7/31/2022
- 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
- Recalling firm
- Perrigo Company PLC
- Quantity
- 65,796 containers
- Distribution
- Nationwide in the USA
- Recall date
- January 12, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)