Simponi Pens Recalled by Johnson & Johnson for Manufacturing Defect

Johnson & Johnson is recalling <"">Simponi injection pens in the U.S. and Germany. According to the company, a potential defect could result in an insufficient dose of the rheumatoid arthritis drug, and patients are being advised to use pre-filled syringes of Simponi as an alternative.

The Simponi pen recall is just the latest in a string of recalls that have cost Johnson & Johnson $900 million in sales over the past year. The tally includes recalls issued by its McNeil Consumer Healthcare division that have involved upwards of 200 million bottles -including children’s formulations – of Tylenol, Motrin and other over-the-counter drugs. Just last week, the company’s Ortho-McNeil-Janssen Pharmaceuticals division recalled prefilled Invega Sustenna syringes, while its Ethicon unit recalled its Dermabond wound care product, as well as its Securestrap Hernia Product, a device used in hernia treatment.

Other Johnson & Johnson recalls have involved two ASR hip implants sold by its DePuy Orthopaedics unit, as well as a recall (an initial action and an expansion) of 100,000 boxes of 1-Day Acuvue TruEye contact lenses.

The Simponi pen recall involves 395 pre-filled pens – 165 sold in the U.S., and another 230 sold in Germany. According to a report in The Wall Street Journal, Johnson & Johnson identified a manufacturing problem at a plant in Switzerland that could result in an incomplete dose of the drug delivered by the pen. While most lots of the defective Simponi pens were quarantined, some made it past the wholesale level.

European health authorities said the manufacturing problems could lead to a shortage of Simponi pens, The Wall Street Journal reported. Johnson & Johnson said it would make new Simponi pens available by the end of February.

Simponi, approved for sale by the U.S. Food & Drug Administration (FDA) in 2009, is used to treat rheumatoid arthritis and other inflammations. It is usually a once-a-month injection and available in the prefilled autoinjector pens or prefilled syringes.

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