Taro Pharmaceuticals U.S.A., Inc. recalls Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Dis…

Recall date

September 27, 2019

Source

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

Recall number

D-0301-2020

FDA classification

Class II

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

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 Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1