D-66272-001 Class II Terminated
FDA drug recall D-66272-001 was initiated by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. on September 6, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed The recall status is terminated (terminated December 2, 2014). Affected quantity: 197,532 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2013
- Initiation Date
- September 6, 2013
- Termination Date
- December 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197,532 bottles
Product Description
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 Pattern
Nationwide.
Code Information
Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15