J&J recalls two lots of Simponi injection devices

Fri Feb 18, 2011 2:27pm EST

* Injection devices may deliver less than full dose

* No problems found with medicine

* 165 in U.S., 230 in Europe being recalled from market

By Bill Berkrot

NEW YORK, Feb 18 (Reuters) - Johnson & Johnson (JNJ.N) said it has recalled two lots of Simponi injection devices -- one in the United States and one in Europe -- after discovering they may deliver less than a full dose of the rheumatoid arthritis medicine.

The potential defect was discovered by the company during regular quality testing and the voluntary recall was initiated earlier this week.

J&J, which has been beset by recalls of more than 250 million bottles of its consumer healthcare medicines as well as other products due to manufacturing and quality control problems, has stepped up inspections at plants across its business universe.

"There is no issue with the Simponi drug product. It is merely the drug delivery device that has a manufacturing issue," Monica Neufang, a business communications spokeswoman for J&J, said of the latest recall.

From the affected U.S. lot of 839 pre-filled injection devices, nearly 80 percent were quarantined at the wholesaler level, the company said of the recall.

"We're working with wholesalers and distributors to recapture the remaining 165 affected units that are in the market," Neufang said.

The percentage fail rate among the affected injection devices is 0.5 percent, the company said.

"If you apply that rate to the 165 units, potentially one device in the marketplace has a defect," Neufang said.

The pre-filled injection devices were manufactured at J&J's Janssen Biologics plant in Switzerland.

The affected lot in Europe was discovered in Germany during part of ongoing quality checks, J&J spokesman Brian Kenney said.

From that lot, 1,890 units were quarantined as a precaution and 230 units made it to market and are being recalled, Kenney said.

J&J is working with Merck & Co (MRK.N), which holds European sales rights to Simponi, to make sure healthcare professionals in Germany are aware of the recall, he added. (Reporting by Bill Berkrot, editing by Gerald E. McCormick)

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