children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free...
FDA Recall #D-0278-2019 — Class II — October 19, 2018
Product Description
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
Reason for Recall
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
Nationwide in the USA
Code Information
Lot # 313344, Exp 12/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.