McNeil Consumer Healthcare’s voluntary recall of 12 million bottles of its Motrin product marks the third consecutive year the Johnson & Johnson business ended the year recalling an OTC drug product.
In a Dec. 21 statement on the Motrin website, McNeil said it is recalling from retailers 59 lots of Motrin IB coated caplets and tablets in 24-count containers and coated caplets in 24+6-count packages -- each product contains 200 mg ibuprofen. The firm said testing of samples showed some caplets may not dissolve as quickly as intended when the products near their expiration date. The lots are being recalled "since there is a chance they could experience a similar problem as they approach expiration,” the J&J business said.
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McNeil said there is no safety concern if the products are used in accordance with the label, but there may be a delay in experiencing relief. Consumers do not need to dispose of or return the products, which were distributed in the U.S., Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
McNeil manufactured the Motrin products at its facility in Las Piedras, Puerto Rico, the same plant that was the source of multiple McNeil OTC brands recalled in late 2009 aand 2010 after consumers reported an odor that was linked to packaging contaminated by a chemical residue from wooden pallets another firm supplied.
In late 2010, McNeil recalled 118 lots of Rolaids softchews – about 13 million packages – distributed in the U.S., after receiving consumer complaints about foreign substances in the antacids, including wood and metal fragments. The affected Rolaids were manufactured at a third-party facility, as “The Tan Sheet” reported here.
The Las Piedras plant is one of three manufacturing facilities subject to a consent decree J&J entered in March with FDA and the Department of Justice, requiring independent audits for five years at the plants and authorizing FDA to extend the requirement. The decree followed an investigation prompted by a string of recalls of OTC products in the Tylenol, Motrin, Zyrtec and Benadryl lines in 2009 and 2010, as we reported here.
McNeil's Fort Washington, Pa., manufacturing facility will remain closed until after an independent expert conducts an audit and FDA determines the site is compliant with good manufacturing practices regulations, according to the decree. Along with the Las Piedras, facility, the Lancaster, Pa., plant is allowed to continue operating while being audited.
A McNeil spokeswoman today said the latest recall of the Motrin products will not affect the terms of the decree.
Meanwhile, a federal judge ruled Dec. 21 that a lawsuit claiming J&J misled investors about quality control-failures at those manufacturing plants will proceed, though the judge dismissed claims against CEO William Weldon and McNeil Consumer President Peter Lutherof, Bloomberg reported here
"The Tan Sheet" reported here that, in response to the investors' lawsuit J&J appointed a committee of board members to prepare a report on the OTC quality-control problems. The committee found root causes for the problems, but absolved the firm's executives of any blame.
-- Malcolm Spicer (m.spicer@elsevier.com)
