McNeil Recalls Motrin Drops After Plastic is Found in Ingredient

Sep 09, 2013
By PharmTech Editors

McNeil Consumer Healthcare Division of McNeil-PPC announced on Sept. 6 a voluntary recall at the retail level of three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor (0.5 fl oz bottles) after 1 mm plastic particles were identified in a different product lot during manufacturing.  The lot in which the particles were discovered was not released to the market.

In a press statement posted on www.FDA.gov and the McNeil website, the company reported that the particles originated in a shipment from a third-party supplier of ibuprofen, the active ingredient in the recalled product.  The company said that, out of an abundance of caution, it was recalling the three lots—approximately 200,000 bottles distributed in the United States—that were made with the same batch of active ingredient.  

The company says it has worked with the third party to ensure that corrective measures are currently in place and the potential for adverse medical events related to the reason for this recall is not likely.   

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.

Sources: FDA and McNeil Consumer Healthcare Division of McNeil-PPC