About 200,000 bottles of concentrated Motrin infant drops were recalled late last week, due to concerns that they may be contaminated with tiny plastic particles.
The Motrin Infant Drops recall was announced on September 6 by the FDA and McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. The recall has not resulted in any reports of illness or injury to date.
Tiny plastic pieces, about the size of poppy seeds, were found in a lot that was never shipped out, the manufacturer reports. However, it was determined that the particles came from a third party supplier of ibuprofen, the active ingredient. That same batch of active ingredient was used in the three lots affected by the recall.
The recall affects lot numbers DCB3T01, DDB4R01, and DDB4S01 of Concentrated Motrin Infants’ Drops Original Berry Flavor, sold in 1/2 fl oz bottles and distributed in the U.S. The bottles have a UPC code of 300450524157 and an NDC of 50580-100-18. The Dye-Free Berry Flavor one ounce drops are not affected by this recall.
McNeil is asking retailers to remove the affected lots from store shelves and are advising consumers who have purchased the recalled bottles to stop using them and dispose of them. The recall makes no mention of compensating consumers who purchased the recalled bottles.
The company says it is working with the supplier to correct the problem, but the recall comes as McNeil and Johnson & Johnson continue to try to crawl out from under the specter of a string of recalls, including a massive children’s drug recall issued in April 2010 due to manufacturing problems.
National attention was focused on Johnson & Johnson’s OTC drugs after an April 2010 recall of Tylenol, Benadryl and Motrin, which affected affected 136 million bottles of children’s medications. That recall resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant and the temporary suspension of the production of all children medications manufactured by their McNeil subsidiary. Inspectors found a number of problems at the facility that included poor quality control measures, and inadequate and sometimes disjointed tracking and responses to consumer complaints.