Pharmaceutical giant Johnson & Johnson's (JNJ) Ortho-McNeil-Janssen Pharmaceuticals, Inc. unit initiated Tuesday a voluntary recall of its 234 mg strength of antipsychotic drug Invega Sustenna or paliperidone palmitate extended- release injectable suspension pre-filled syringes.
The company noted that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration, and was announced on Friday.
The Titusville, New Jersey-based company has recalled ten lots of syringes with expiry date ranging from September 2011 to December 2012.
The company noted that the recall was initiated after detection crack in the syringe barrel in some of the syringes, which is completely covered by the label and is not detectable by the user.
The company noted that 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.
However, the company added that based on available data, the risk for infection or reduced dosage potentially resulting in reduced efficacy is considered low.
Meanwhile, the company revealed that there have been no reports to date of any adverse events of infection associated with the identified batches since product launch and no reports of product complaints of leakage associated with cracked syringe barrels.
Janssen is focused exclusively on mental health and offers prescription medications for the treatment of schizophrenia, schizoaffective disorder, bipolar 1 disorder, and irritability associated with autistic disorder.
JNJ closed Tuesday's regular trading session at $60.62, down $0.08 or 0.13 percent on a volume of 8.57 million shares.
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