Tylenol Recall Broadens; Includes Extra Strength, Benadryl

The company advised consumers who purchased the affected products to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.

Prior to the Jan. 15 recall, the FDA had cited at least two of the company's products in a letter to McNeil, as these products had been the subject of complaints about an "uncharacteristic smell," similar to the one that helped trigger the recall of the arthritis caplets.

"Since the date of the discovery, your firm did not extend the assessment of the event to other products that received packaging components from the same supplier," said the FDA's letter, which was signed by Jose R. Lopez, an investigator, and Raquel Gonzalez Rivera, a chemist.

The letter went on to cite over 10 "musty-moldy odor" complaints about Rolaids and over 39 similar complaints about Tylenol Extra Strength, "including three adverse event reports."

The letter is dated Jan. 8, 2010, but was posted to the FDA's Web site Jan. 13.

"Certainly, the FDA report raises serious questions about the manufacturer's response," said Robert Field, professor of health management and policy at the Drexel University School of Public Health. "The report has found that the investigation was limited...that the procedures for quality control were not in writing...and various other lapses that were fairly significant."

The FDA report further criticized McNeil for inadequate responses to complaints, noting that they first received heightened complaints about the musty odor in 2008 and testing confirmed its presence in September of that year.

"Your quality unit failed to conduct additional testing to evaluate the possibility of chemical contamination or other change or deterioration in the distributed drug product," the FDA letter says.

Karen Hirshfield, acting branch chief of the FDA Office of Compliance's Recalls and Shortages Branch, revisited these concerns during this morning's briefing.

"We would have expected McNeil to expand their investigation when they first learned of consumer complaints on this issue," she said. "They became aware of a problem in September 2008, and their investigation and report to [the FDA] didn't occur until about a year later. We would have expected action to occur sooner than that."

Effects of Tainted Pills Not Deadly

One positive for consumers is that, as ABC News Senior Medical Editor Dr. Richard Besser noted in December, after the first recall was announced, the effects of the tainted pills were not life threatening.

"They're not that severe, we're talking about vomiting, diarrhea," said Besser. However, he advised, "if you have this product, you should get rid of them, safely dispose of them in your trash. You don't want them around."

Field agreed, following news of the initial recall.

"It does not look like there were serious health effects, if any," he said, "but why take a chance? These products are supposed to improve your health, not hurt it."

ABC News correspondent David Kerley contributed reporting from Washington, D.C.

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