FDA recall D-0301-2020

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

Product

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

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-09-27
Report date: 2019-11-06
Termination date: 2023-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2020