D-0300-2020 Class II Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
November 6, 2019
Initiation Date
September 27, 2019
Termination Date
August 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
182,986 bottles

Product Description

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8

Reason for Recall

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

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: E875131667, E875231667, Exp 4/20; J871033189, J871133189, Exp 9/20; A972934375, A973034375, Exp 12/20