CAREONE Allergy Relief recall: Impurity Out of Spec
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
Why was CAREONE Allergy Relief 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 a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022
- Product
- 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
- Recalling firm
- Perrigo Company PLC
- Quantity
- 28776 containers
- Distribution
- Nationwide in the USA
- Recall date
- January 12, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)