A unit of Johnson & Johnson announced a nationwide recall on Thursday of all lots — more than 13 million packages — of the soft chewable versions of Rolaids, its popular antacid drug, after reports of consumers finding metal and wood particles in the products.
The unit, McNeil Consumer Healthcare, has been troubled by manufacturing deficiencies over the last year, which has led to a series of recalls of some of the country’s most popular over-the-counter brands. A recall in April alone involved about 136 million bottles of liquid children’s Tylenol and other pediatric products.
Although McNeil said early this year that it was instituting a comprehensive plan to improve its manufacturing and quality control systems — including the temporary closure of a plant in Pennsylvania for an upgrade — some manufacturing problems have continued.
The foreign particles found in the Rolaids were potentially introduced during production at a third-party manufacturer, McNeil said in a statement. McNeil declined to identify the manufacturer.
The recall involves all lots of Rolaids Extra Strength Softchews, all lots of Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews sold in the United States. While the risk of health problems is remote, McNeil said consumers should stop using the Rolaids involved.
Also on Thursday, Wells Fargo downgraded shares of Johnson & Johnson to market perform, citing risks associated with McNeil’s problems.
Last month, for example, the Food and Drug Administration posted a report on its Web site citing a McNeil plant in Puerto Rico that was inspected this fall for manufacturing problems. The report cited the facility for, among other issues, distributing products that failed quality requirements, failing to identify product defects during routine testing, failing to adequately investigate product problems and inadequate training of laboratory staff.
In an interview last month, Karen Riley, an F.D.A. spokeswoman, said the report indicated that McNeil “continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law.”
Earlier this year, the agency said its office of criminal investigations had opened an inquiry into the company’s conduct surrounding the recent recalls.
Separately, the House Committee on Oversight and Government Reform has held two hearings in which legislators questioned company executives and F.D.A. officials about their conduct in the recalls.
The Rolaids recall “reinforces the committee’s ongoing investigation surrounding the safety protocols in place at J.& J.’s facilities and how the F.D.A. is managing food and drug safety,” Kurt Bardella, a spokesman for the committee chairman-designate, Representative Darrell Issa, Republican of California, said. “The committee is in the process of and will continue to seek answers from J.& J. and the F.D.A.”
Johnson & Johnson executives estimated earlier that the recalls and closure of the Pennsylvania plant would reduce sales by about $600 million this year.
In a note to investors on Thursday, Larry Biegelsen, an analyst at Wells Fargo, estimated that there was a 25 to 50 percent chance that McNeil would close the plant in Puerto Rico because of the latest F.D.A. report.
“We believe there is risk to JNJ’s McNeil” over-the-counter business in 2011, he wrote, “and see few potential offsets and prefer to stay on the sidelines until there is some clarity.”
In September, Johnson & Johnson said that the executive in charge of the consumer business, including McNeil, would retire in March, a move analysts interpreted to mean that she was taking the blame for the problems.
In the latest recall, McNeil said it had suspended production of the Rolaids products and would not restart production until it had taken corrective actions.
Consumers who bought the products may call 1-888-222-6036 or go to www.rolaids.comfor instructions about a refund, McNeil said.
Since the problems with Tylenol and other children’s liquid medicines this spring, the company has heightened its vigilance in recalling products that may not meet manufacturing standards.
Last month, for example, after a review identified manufacturing problems, McNeil recalled nine million bottles of liquid Tylenol Cold Multi-Symptom to update labels, 71,000 packages of soft chewable Rolaids because of an unusual texture caused by crystallized sugar, four million packages of Benadryl and 850,000 bottles of Motrin.
Unlike Thursday’s consumer recall, the November recalls were at the wholesale and retail levels. That meant stores stopped selling the products, but people could continue to use them, McNeil said.
Other Johnson & Johnson units have experienced problems this year. In August, for example, the DePuy Orthopaedics unit recalled two kinds of hip implants because many patients required a second replacement after the implants failed.