Drug recall D-0277-2019

Class II Terminated reported Nov 21, 2018

Product

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.

Reason for recall

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Lots and codes

Lot # 313345, Exp 12/18

Recall details

Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Quantity
8328 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 19, 2018
Terminated
November 3, 2020

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