PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 21, 2018 Initiated: October 19, 2018 #D-0276-2019

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.

Details

Units Affected
12,432 bottles
Distribution
Nationwide in the USA
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 12,432 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 21, 2018. Severity: Moderate. Recall number: D-0276-2019.