FDA is investigating hundreds of consumer complaints involving children's medicines recalled by Johnson & Johnson on April 30, according to a congressional memo, the Associated Press reported.
FDA is investigating hundreds of consumer complaints involving children’s medicines recalled by Johnson & Johnson on April 30, according to a congressional memo, the Associated Press reported. The agency has not directly linked any of the complaints to flaws in products made by the New Brunswick, N.J.-based company.
Johnson & Johnson recalled more than 40 varieties of children’s cold medicines after FDA inspectors discovered a slew of manufacturing problems at its Fort Washington, Pa., facility. The recall, the company’s third during the past year, triggered a flurry of criticism from lawmakers.
Since the recall, FDA has received hundreds of reports of complications with Johnson & Johnson products, including seven deaths, according to a memo distributed to congressional staffers and obtained by the Associated Press.
FDA is investigating whether the problems are linked to flaws in Johnson & Johnson products, which include infant Tylenol, Benadryl, and Motrin. “At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” according to the congressional memo.
FDA inspectors found that Johnson & Johnson failed to investigate medications that had potentially unsafe potency levels, according to FDA documents cited in the memo. While the company rejected three batches of Infant Tylenol found to be overly potent, the company failed to check seven other batches potentially at risk for the same issue.
In another instance, FDA found that Johnson & Johnson did not recall a batch of products potentially infected with bacteria. The products were in distribution last fall, according to FDA.
In testimony before the U.S. House of Representative’s Committee on Oversight and Government Reform on May 27, Colleen A. Goggins, worldwide chairman, Consumer Group for Johnson & Johnson, said McNeil implemented a broad, precautionary recall of liquid medications for children and infants because quality-process deficiencies produced tiny metal particles in a small amount of product.
“The recall was not prompted by adverse medical events, nor was it prompted by safety concerns regarding two additional quality issues referenced in the recall notice - excess concentration of active ingredient and inactive ingredients that did not meet McNeil’s testing requirements,” Goggins testified. “We believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services. In this instance, we have not lived up to that responsibility.
“Even though we were relieved that the medical risks were remote, we recognize that quality-process deficiencies are important and must be remedied,” she added.