Taro Pharmaceuticals U.S.A., Inc. recalls Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 F
Recalled November 21, 2018 · FDA recall D-0276-2019 · Taro Pharmaceuticals U.S.A
Hazard
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. · FDA Class II
Units
12,432 bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Product
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.
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →