McNeil Consumer Healthcare Division is voluntarily recalling at the retail level 200,000 bottles of Concentrated Motrin Infants’ Drops Original Berry Flavor 1/2 fl oz bottles. The full product recall list is available here.
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.
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) 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.
McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. McNeil has worked with the third party to ensure that corrective measures are in place and are effective. The potential for adverse medical events related to the reason for this recall is not likely.
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.
Health care professionals 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.
September 9, 2013 — FDA safety alert