FDA-Drug2018-11-21Class II
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.
Taro Pharmaceuticals U.S.A., Inc.
Hazard
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Sold states
Nationwide in the USA
Affected count
8328 bottles
Manufactured in
3 Skyline Dr, Hawthorne, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2019Don't want to check this manually?
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