FDA recall D-66272-001

Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. · Class II · 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.

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2013-09-06
Report date: 2013-10-23
Termination date: 2014-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fort Washington, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66272-001