Invega Sustenna Syringes Named in Latest Johnson & Johnson Recall

Beleaguered drug maker Johnson & Johnson has issued yet another recall, this time involving syringes containing an injectable form of the antipsychotic Invega Sustenna. The <"">Invega Sustenna syringe recall was issued yesterday by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals, Inc. unit after cracks were discovered in some of the products.

Invega Sustenna is an injectable formulation of Invega that can be administered monthly for treatment of schizophrenia. According to the Associated Press, Invega, which was approved in December 2006, is related to the antipsychotic Risperdal.

The cracks in the Invega syringes could put patients at risk for serious infections. According to The Wall Street Journal, Johnson & Johnson has received one report of an adverse event in Australia that may be related to the cracks. However, the company would not provide details on that incident.

The Invega Sustenna syringe recall involves ten lots (70,000 syringes) with expiry date ranging from September 2011 to December 2012. Janssen sent an <"">Invega Sustenna recall notice to distributors, pharmacists and health-care providers on February 11. The recall affects products sold in the U.S., Australia, Canada and South Korea.

The syringes contain Invega Sustenna at the 234 mg strength. The cracks were discovered in the syringe barrel, which is completely covered by a label and is not detectable by the user. According to Johnson & Johnson, the crack on the syringe barrel could compromise the sterility of the syringe contents and a leakage could result in a lower than intended therapeutic dose.

According to the Associated Press, the Invega Sustenna syringe recall impacts most available inventory of the 234-mg strength drug, but Janssen expects to resume shipping product in early March and returning to normal levels of product availability in April.

According to The Wall Street Journal, the Invega Sustenna syringe recall is just the latest in a String of recalls that have cost Johnson & Johnson $900 million in sales over the past year. That 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.

Other Johnson & Johnson recalls have involved two <"">DePuy hip replacement 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. These  withdrawals, including probable DePuy knee recall, are also weighing on Johnson & Johnson’s performance, as profits for the fourth quarter fell 12 percent.

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