Invega Sustenna Recall Issued for 70,000 Syringes by Johnson & Johnson

About 70,000 syringes filled with Johnson & Johnson’s antipsychotic drug Invega Sustenna have been recalled after it was discovered that some of the syringes were cracked. 

The Invega Sustenna syringe recall (pdf) was announced by Johnson & Johnson subsidiary Janssen on its website on February 11.

The cracks in the syringes, which could compromise the drug’s sterility, are completely covered by the label and are not detectable by the user.

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In addition to problems with sterility, the recalled Invega syringes could also result in patients receiving lower than expected doses of medication, although this risk is reportedly small. There have been no reports of injuries or adverse effects as a result of the cracked syringes.

The syringe recall applies to Invega Sustenna (paliperidone palmitate 234 mg) Extended-Release Injectable Suspension with NDC 50458-564-01 and lot numbers 9IBK000, 9IBK001, 9IBK002, 9IBK003, 9IBK004, 9IBK005 and 9JBK000 with expiration dates including 09/2011, 12/2011, 02/2012, 05/2012 and 12/2012. It also affects sample packages with the NDC 50458-564-03 and lot numbers 9JBK000, 9JBK001 and 9IBK000 and expiration dates of 08/2012 and 12/2011. The recall affects only the 234 mg strength version of the drug.

Invega Sustenna is a once-a-month atypical antipsychotic approved by the FDA to treat schizophrenia. Worldwide sales of Invega were $424 million in 2010.

Johnson & Johnson is asking pharmacies and health care providers to examine their inventories for the recalled syringes and discontinue distribution and use of those products. They are also being asked to forward the recall notice on to any hospitals, clinics or health care professionals to whom they may have sold the syringes.

Customers can contact Stericycle at 1-888-376-2051 for a return package in order to receive a refund or credit.


  • CandaceApril 13, 2012 at 6:08 pm

    I just sent a comment in and incorrectly said the broken syringe was Invega Sustenna. it was Risperdal Consta.

  • CandaceApril 13, 2012 at 5:56 pm

    Any information regarding injuries to those injecting the Invega when the syringe shatters?

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