Safety Alerts & Recalls

What does this mean?

Healthcare providers and pharmacies have been notified of this recall and the recalled lots will no longer be administered to patients. Additional supply of unaffected Invega Sustenna will soon be available.

The risk for infection or reduced efficacy from use of a recalled lot of Invega Sustenna 234 mg is low. That said, if you or someone you care has received injections of Invega Sustenna 234 mg, you should follow up with your doctor if you think your medicine is not working as well, if you are experiencing concerning side effects, or if you are experiencing signs of an infection such as unusual redness or swelling at the site of injection, fever or chills.

Janssen Recalls 10 Lots of Invega Sustenna Syringes

Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. has recalled about 70,000 syringes of the 234 mg strength of the antipsychotic medicine Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension. These syringes are being recalled because the company detected that some of the syringes contained a crack in the syringe barrel. The crack is completely covered by the label and is not detectable by the healthcare professional administering the dose.

Janssen said the cracks could possibly affect the sterility of the syringe contents and possibly result in infections at the injection site or a more serious blood infection. Leakage of the drug through the crack could result in a lower-than-intended dose if the product is administered. According to the press release, there have been no reports of any adverse events of infection associated with the identified batches and no reports of product complaints of leakage associated with cracked syringe barrels. Janssen said the risk for infection or reduced efficacy is considered low.

The recalled lot numbers include: Invega Sustenna (paliperidone palmitate 234 mg) Extended-Release Injectable Suspension, trade: 9IBK000, 9IBK002, 9IBK003 9IBK004, 9JBK000, 9IBK005, 9IBK001

Invega Sustenna (paliperidone palmitate 234 mg) Extended-Release Injectable Suspension, samples: 9JBK000, 9JBK001, 9IBK000

Invega Sustenna is an injectable formulation of Invega that can be administered monthly for treatment of schizophrenia. This recall only involves select lots of Invega Sustenna 234 mg that is administered by injection by healthcare professionals. The tablet form of Invega is not involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-02-17
Last Updated: 2011-02-17

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