Johnson & Johnson's consumer healthcare unit said on Friday it is recalling about 200,000 bottles of concentrated Motrin drops for infants due to potential contamination with plastic particles.
The company is asking U.S. retailers to remove the affected half-ounce bottles of original berry flavored drops from store shelves. It said consumers should dispose of any recalled product they may have and suggested they contact the company about refunds.
Three lots are being recalled because plastic particles, about the size of a poppy seed, were identified during the manufacturing of a fourth, undistributed, lot of the drops.
J&J said it determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in the Motrin drops.
The company said in a statement that it has worked with that supplier to ensure that corrective measures are in place, and said use of the drops is unlikely to cause adverse medical reactions.
In 2010, J&J took more than 40 nonprescription products off store shelves, including Children's Tylenol, after investigators identified problems at its Fort Washington, Pennsylvania manufacturing plant, in what the U.S. Food and Drug Administration has characterized as the largest recall of children's medicine in the agency's history.
The company agreed in July to pay $22.9 million to end a lawsuit from investors who claimed it concealed quality-control failures.
(Reporting By Deena Beasley; Editing by Ken Wills)