For the second time in 2010, a unit of Johnson & Johnson has recalled Tylenol and other over the counter drugs because of production problems.
The glitches are more likely to cause corporate embarrassment than pose a serious health risk. The latest recall involves drugs for children manufactured at a Fort Washington, Pa., facility run by McNeil Consumer Healthcare, a unit of Johnson & Johnson.
On Friday, McNeil voluntarily recalled seven Tylenol, Motrin, Zyrtec, and Benadryl liquid medicines for children and infants because they might not meet required quality standards. Among the problems were higher than specified concentrations of active ingredients and the presence of tiny particles, the Food and Drug Administration said.
"While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use," the agency said. The medicines were distributed in the United States, Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait.
Customers should check the NDC number on the medicine labels against the list of products in the company's press release, says McNeil spokesman Marc Boston. If they match, they should either call 888-222-6036 or visit www.mcneilproductrecall.com for a refund or free replacement.
Friday's action marks the second recall involving Tylenol this year. In January, McNeil recalled Tylenol and other over-the-counter drugs because of a musty odor emanating from the products made in a Puerto Rican facility.
At the time, the FDA criticized the company because it took 18 months after initial complaints before McNeil issued a recall. The problem was eventually linked to the use of chemically treated wooden pallets.
This time, the FDA characterized the problems as "manufacturing deficiencies."
McNeil has not revealed the nature of the problem, how many complaints it got, or how long it took before the recall. But Mr. Boston did say the company would undertake corrective actions before any new manufacturing took place at the Fort Washington facility.