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FDAFDA · Food and drugs·Recall number D-0277-2019

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.

Published November 21, 2018 · Recall initiated: October 19, 2018

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: unknown impurity higher than the specified limit was detected during routine stability testing.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CHILDRENS ALLERGY
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Distributor
Nationwide in the USA
UPC
0041415435735
Lot
Lot # 313345, Exp 12/18
Risk classification
Class II
Area (FDA)
drug
Country
United States

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