The diversified healthcare company, in a press release, said it was recalling the lots after inadvertently failing to include them in a wider recall of over the counter drugs on January 15.
The company’s McNeil Consumer Healthcare unit said the latest action is a “follow-up” to the recall in January. On that occasion, 53 million bottles of a range of products were recalled after consumers complained of musty or moldy odors. The brands included Tylenol and Motrin painkillers, Rolaids, Benadryl and St. Joseph’s Aspirin.
All told, the J&J unit has issued four product recalls in the past year due to quality control problems at its plants, sparking a Congressional investigation and ongoing scrutiny by the U.S. Food and Administration.
“This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson,” Edolphus Towns, chairman of the U.S. House of Representatives Oversight and Government Reform Committee Chairman, said in a statement.
“I am troubled by what we have learned so far in our investigation and this latest development adds to my concern.”
J&J declined to comment on Towns’ statement.
The drugmaker said the odor that prompted its January 15 recall was linked to traces of a chemical called TBA, caused by the breakdown of a chemical applied to wood used to build pallets that transport and store product packaging materials.
“Further analysis confirms that the risk of serious adverse medical events is remote,” J&J said on Tuesday.
J&J said the newly recalled lots — made at a plant in Las Piedras, Puerto Rico — were sold in the United States, Trinidad and Tobago, Bermuda and Puerto Rico.
One of McNeil’s two other main factories, located in Ft. Washington, Pennsylvania, has been shut down while the company strives to fix multiple deficiencies cited by the U.S. Food and Drug Administration.
“From a financial standpoint this really won’t have much of an impact on earnings, but it’s more of a concern to the strength of the Johnson & Johnson brand name,” said Morningstar analyst Damien Conover.