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Recall Observatory FDA recall evidence

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

D-0301-2020

September 27, 2019

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 83887
Status
Terminated
Classification
Class II
Quantity
5,190 bottles
Official record key
drug-enforcement:D-0301-2020

Official wording

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

Code information: Lot #: J871033187, Exp 9/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance