A14 The Nation by Lyndsey Layton Federal officials who inspected


a Johnson & Johnson manufac- turing plant that makes Mylanta, Pepcid and other popular heart- burn medicines unearthed qual- ity control problems, chaotic rec- ordkeeping and complaints by consumers that medicines were either ineffective or contained pills from different products in the same retail package. The facility in Lancaster, Pa., is


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the third Johnson & Johnson plant to be flagged this year by the Food and Drug Administration for serious manufacturing defects —an unusual number for a single company. The FDA’s latest report was re- leased Wednesday, a day after Johnson & Johnson told investors it had received a subpoena from a grand jury in eastern Pennsylva- nia. The company is also the sub- ject of a congressional probe into recalls this year of more than 100 million bottles of adult and chil-


dren’s Tylenol, Motrin, Benadryl and Zyrtec and other over-the- counter medicines. The company has not recalled


any products made in the Lancas- ter facility, which is a joint ven- ture with Merck. Spokesman Marc Boston said the joint ven- ture “takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible.” FDA officials who inspected the


Lancaster facility from June 22 to July 9 documented 12 deficien-


cies, including the failure to inves- tigate why some consumers found maximum-strength tablets in reg- ular-strength Pepcid bottles, or mint-flavored tablets in berry-fla- vor bottles. That kind of error, ex- perts say, suggests both a lapse in the manufacturing process as well as weak quality controls. The FDA inspection took place about a month after a top John- son & Johnson executive testified on Capitol Hill that the company was working feverishly to address all shortcomings and restore con-


sumer confidence. In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chem- ical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gas- trointestinal problems. It was the first of four recalls of


Johnson & Johnson products in the past year, including the April


SATURDAY, JULY 24, 2010 FDA reports problems at a third Johnson & Johnson facility


30 recall of 136 million bottles of infant and children’s Tylenol, Mo- trin, Benadryl and Zyrtec. Those products were recalled after FDA inspectors found widespread manufacturing problems at the Johnson & Johnson facility in Fort Washington, Pa., the only plant where they were being made. The company has temporarily shut down the Fort Washington plant. The affected products will not be back on store shelves until next year.


laytonl@washpost.com


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