Taro Pharmaceuticals U.S.A., Inc. recalls children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL O…

Recall date

October 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0278-2019

FDA classification

Class II

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.