47 million packages of Tylenol, Sudafed recalled

FORT WASHINGTON, Pa — Johnson & Johnson said Friday it is recalling nearly 47 million packages of Tylenol, Sudafed and other nonprescription drugs manufactured at a Pennsylvania facility that has already been subject to a series of massive recalls, battering the company's household brand.

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The latest recall affects certain lots of Tylenol, Benadryl and Sudafed products because of insufficient cleaning procedures, though the company does not believe that quality was impacted. The company also recalled certain lots of Rolaids tablets because they do not include certain labeling information.

The recalls are aimed at wholesalers in the U.S., the Caribbean and Brazil. Consumers do not have to take any action, the company said. Consumers who have the products can continue using them.

All of the products were made at the company's plant in Fort Washington, Pa., before it was shuttered in April following a Food and Drug Administration investigation. FDA inspectors found a slew of manufacturing problems at the plant, including equipment covered with thick layers of dust and others held together with duct tape.

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J&J issued several recalls related to the problems, the largest of which involved more than 135 million bottles of infants' and children's Tylenol and other medicines.

New Brunswick, N.J.-based J&J said the latest round of recalls related to its review of internal manufacturing at the Fort Washington plant going back to 2007. The company said certain manufacturing standards had not been followed and some products did not include all the labeling information required by regulations.

The company said it recently completed the review, which is one requirement of a broader remediation plan required by the FDA.

J&J is conducting additional reviews at other manufacturing sites.