D-0276-2019 Class II Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
November 21, 2018
Initiation Date
October 19, 2018
Termination Date
November 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,432 bottles

Product Description

Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 313342, Exp 12/18