FDA recall D-0299-2020

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

Product

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9

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-0299-2020