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Recall Observatory FDA recall evidence

Drug product

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 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 51672-1385-8

D-0298-2020

September 27, 2019

Class II

Product summary

Firm
Taro Pharmaceuticals U.S.A., Inc.
Event
Event 83887
Status
Terminated
Classification
Class II
Quantity
138,886 bottles
Official record key
drug-enforcement:D-0298-2020

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 #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance