Taro Pharmaceuticals U.S.A., Inc. recalls children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120
Recalled November 21, 2018 · FDA recall D-0277-2019 · 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
8328 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 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.
Manufacturer(s)
Taro Pharmaceuticals U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →