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Recall Observatory FDA recall evidence

Drug product

Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.

D-66272-001

September 06, 2013

Class II

Product summary

Firm
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Event
Event 66272
Status
Terminated
Classification
Class II
Quantity
197,532 bottles
Official record key
drug-enforcement:D-66272-001

Official wording

Reason: Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed

Code information: Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15

Distribution pattern: Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance