McNeil Consumer Healthcare Division of
McNEIL-PPC, Inc. (“McNeil”) 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.
This recall is being
conducted with the knowledge of the U.S. Food and Drug Administration
(FDA). 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.
FULL RECALLED PRODUCT LIST:
| Product | Lot # | UPC Code | Case UPC Code |
|---|---|---|---|
| Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles NDC 50580-100-18 |
DCB3T01 | 300450524157 | 30300450524158 |
| DDB4R01 | |||
| DDB4S01 |
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, the company 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 currently 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.