Simponi Recall Could Lead to Temporary Shortage of Arthritis Drug

A recall of auto-injectors filled with the rheumatoid arthritis drug Simponi has led to warnings that there may be a temporary shortage of the drug in some places.  

A Simponi autoinjector recall was announced Friday for the United States and Germany after it was discovered that a manufacturing defect could result in insufficient doses of the drug in some of the autoinjectors.

After the recall was announced, the European Medicines Agency (EMA) warned that the recall, despite its small size, could result in a shortage of the drug (pdf) because Johnson & Johnson will not start to make new prefilled injectors, often known as pens, until the end of February and do not expect the new pens to be available for consumers until the end of March. 

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Simponi, approved in the U.S. by the 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. The EMA warned that the prefilled syringes may not be available everywhere the Simponi pens are available. 

The recall affects at least 395 Simponi 50 mg single dose Smarject autoinjectors distributed in the United States and Germany. The recalled Simponi pens have a lot number of 09D071.AC. 

Johnson & Johnson subsidiary Centocore Ortho Biotech Inc. is recommending that consumers affected by the recall consult with a physician about temporarily using the prefilled syringes instead of the Simponi pens.

The Simponi recall came after Ethicon, Inc., another Johnson & Johnson subsidiary, recalled 700,000 vials of Dermabond Topical Skin Adhesive earlier this month because batches were discolored and may have prolonged setting times. The Dermabond recall (pdf), announced on February 2, affects almost 30 lots. No injuries or illnesses have been reported in connection to that recall. 

Ethicon also issued a recall for Securestrap, a hernia repair tool that the company said might have been shipped in nonsterile packaging. However, very few of the Securestraps got out of the company’s control and those hospitals that received the recalled Securestraps were quickly identified.

The Dermabond recall affects a Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive with product codes DHV12 and DPP6. See the recall press release for a full list of lot numbers and detailed directions on returning recalled Dermabond. 

There have been no adverse events reported in connection to either defective Simponi or discolored Dermabond. Customers with questions about the Simponi recall can call the company’s Customer Contact Center at 877-526-7736. Customers with questions about the Dermabond recall can call 1-866-869-7954.

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  • WarrenFebruary 21, 2011 at 5:14 pm

    My wife, Cheryl, has been using Dermabond successfully for her ostomy bag for the last 18 months with no adverse effects. She uses about one vial per day and is very pleased with the results. This recall has bumped the price up by 65% and puts a real crimp in our medical budget. We would like the recall to be resolved soon so the price can revert to previuosly affordable levels.

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