Reported Jan 12, 2022 · Terminated
MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major…
Perrigo Company PLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Perrigo Company PLC · 515 Eastern Ave · Allegan, MI · 49010-9070
Is this the product you have?
- 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
- Lot codes and dates
Lot 0GR0445Exp 1/31/20220LR0361Exp 4/30/20221AR0558Exp 7/31/2022
- Amount recalled
- 65,796 containers
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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