Johnson & Johnson said Friday that it was recalling from wholesalers nearly 47 million packages of Tylenol, Sudafed, and other nonprescription drugs that were made in Fort Washington.
The company said its own investigation showed that some equipment used in production was not cleaned properly, although it said it did not believe the drugs' quality was affected.
The Montgomery County plant, operated by J&J's McNeil Consumer Healthcare Division, was voluntarily shut and children's medications were recalled in April in response to a Food and Drug Administration report that said raw ingredients contaminated with bacteria had been used in some products. The FDA said it had found no evidence of bacteria in any finished products it tested.
The recall announced Friday affects Tylenol 8-Hour, Arthritis, and upper-respiratory products, as well as certain lots of Benadryl, Sudafed PE, and Sinutab products distributed in the United States, Brazil, and the Caribbean, J&J, of New Brunswick, N.J., said.
The action is being taken at the wholesale level and no action is required by consumers, the company said. The products were made in Fort Washington before April. McNeil has recalled dozens of drugs since then, drawing concerns from Congress, the FDA, and consumer groups.
"McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products," the company said in Friday's announcement. "The actions being undertaken as a result of the assessment are part of McNeil's ongoing commitment to ensure that all its products meet the high quality standards that consumers expect."
J&J also announced the wholesale recall of certain lots of Rolaids Multi-Symptom berry-flavored tablets that were found to not include required information in the product labeling.
None of Friday's recalls was the result of patient side effects, the company said.
J&J reviewed records dating back to 2007 and "identified a number of areas for improvement," the company said in a separate statement. The McNeil unit is conducting assessments at its other manufacturing sites, J&J said in the statement.
"If these reviews reveal any further issues, McNeil will not hesitate to take whatever steps are needed to ensure that its products meet world-class quality standards, including further market action if warranted," J&J said in the statement.
The Fort Washington plant was at the center of the recalls. J&J has said the facility will not reopen until late this year.
J&J shares fell 36 cents, or less than 1 percent, Friday to $62.55 in New York Stock Exchange composite trading. The company's shares have declined 3.9 percent in the last 12 months.
The Associated Press contributed information to this article.