Drug recall D-0300-2020

Class II Terminated reported Nov 6, 2019

Product

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.

Lots and codes

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

Recall details

Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Quantity
182,986 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 27, 2019
Terminated
August 31, 2023

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