J&J hit by another string of product recalls
pharmafile | February 21, 2011 | News story | Manufacturing and Production | J&J, JJ, Johnson & Johnson, Simponi, golimumab, manufacturing compliance, pharma recalls
There seems to be no end to the quality troubles plaguing Johnson & Johnson, with several more recalls to report, including a pull back of the company’s rheumatoid arthritis Simponi in the US and Germany.
The recall could lead to shortages of Simponi (golimumab), according to a European Medicines Agency (EMA). The reason given for the recall is a defect in some of the pen injector devices used to administer the product, which could lead to sub-therapeutic dosing.
Production of new pen injectors will start at the end of this month, but the EMA anticipates that the recall of around 400 units, along with a stop on shipments of the remainder of the production run, will lead to shortages in some European countries lasting until May.
“To deal with the shortage … patients should be switched to the other presentation of Simponi, the pre-filled syringe, or to alternative treatments as advised by their doctors,” said the EMA in a statement.
Simponi was approved in 2009 as a once-monthly subcutaneous treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The drug is currently at the centre of a dispute between J&J and Merck & Co, which inherited marketing rights to the drug its acquisition of Schering-Plough.
The Simponi recall comes after another series of J&J recalls, including most recently 70,000 pre-filled syringes of the firm’s Invega Sustenna (paliperidone palmitate) drug for schizophrenia after cracks were found in the syringes which could affect sterility and dosing.
Just before that, J&J subsidiary Ethicon recalled 700,000 vials of Dermabond liquid wound sealant after reports of discoloration, and its Securestrap hernia treatment device on fears that the affected units may not be sterile.
In January J&J also revealed another recall of its over-the-counter products – this time affecting more than 43 million units of Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products, as well as various lots of Benadryl, Sudafed PE and Sinutab products. The products were manufactured at J&J’s plant in Fort Washington prior to its shutdown last April, and the recall was initiated after a review of production records found that the batches may have been produced using improperly cleaned equipment.
2011’s crop of recalls comes after millions more products were pulled back in 2010, costing the firm an estimated $900 million in lost revenues.
Phil Taylor
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