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www.fdanews.com/articles/172203-closed-jj-pennsylvania-facility-to-reopen-soon
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Closed J&J Pennsylvania Facility to Reopen Soon

July 20, 2015

A Johnson & Johnson factory that closed in 2010 after being at the center of massive recalls of over-the-counter products is close to reopening, the company said.

A total of 43 million bottles of Tylenol (acetaminophen), Benadryl (diphenhydramine) and Sudafed (pseudoephedrine) products were recalled and J&J’s Fort Washington, Pa., facility was gutted and rebuilt after metal particles were found in children’s Tylenol.

Recalls also hit widely used drugs including Zyrtec (cetirizine) and Motrin (ibuprofen), which were found to be subpotent.

All products manufactured at the plant, along with plants in Lancaster, Pa., and Las Piedras, Puerto Rico, had to be destroyed.  The Lancaster and Las Piedras sites were allowed to remain open after undergoing a comprehensive current good manufacturing practice implementation plan.

The Fort Washington plant recently underwent an FDA inspection and is awaiting final notification from the agency that it can resume manufacturing operations, said Sandi Peterson, J&J’s worldwide chairman overseeing the company’s consumer health business.

Peterson said issues that plagued the company’s OTC business have been remediated and products have been relaunched, with more than 80 percent of their brands returning to the market.

Those plants were recently inspected and certified by the FDA. — Kellen Owings