FDAFDA · Food and drugs·Recall number D-0334-2022
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
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
- Brand
- CAREONE ALLERGY RELIEF
- Manufacturer
- Perrigo Company PLC
- Distributor
- Nationwide in the USA
- UPC
- 341520319846
- Lot
- Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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