FDA recall D-0276-2019

Taro Pharmaceuticals U.S.A., Inc. · Class II · drug

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-10-19
Report date: 2018-11-21
Termination date: 2020-11-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2019