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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, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

D-0302-2020

September 27, 2019

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 83887
Status
Terminated
Classification
Class II
Quantity
5,280 bottles
Official record key
drug-enforcement:D-0302-2020

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 #: A972834374, Exp 12/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance