FDA recall D-0278-2019

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

Product

children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.

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-0278-2019