AUDIENCE: Consumer, Pharmacy, Patient, Health Professional
ISSUE: McNeil Consumer Healthcare is voluntarily recalling at the retail level three lots, approximately 200,000 bottles, of Concentrated MOTRIN Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States (refer to Firm Press Release for full product list).
After releasing these three lots of Concentrated MOTRIN Infants’ Drops Original Berry Flavor 1/2 fl oz into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing. This lot was not released to the market. It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in Concentrated MOTRIN Infants’ Drops Original Berry Flavor 1/2 fl oz. Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient.
BACKGROUND: Concentrated Infants’ MOTRIN Drops Dye-Free Berry Flavor 1 fl oz is not included in this recall. Children’s or Adult MOTRIN products are not included in this recall.
RECOMMENDATION: McNeil is asking retailers to remove the affected lots from store shelves, and is asking consumers to stop using and dispose of any product they may have that is included in this recall.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/06/2013 - Firm Press Release - FDA]
[09/06/2013 - Product Photo - FDA]