Janssen, a division of Johnson & Johnson unit Ortho-McNeil Janssen Pharmaceuticals, has recalled approximately 70,000 prefilled syringes containing the drug Invega Sustenna, an antipsychotic drug, due to some of the syringes having cracks in the side. The cracks have the possibility of affecting the sterility of the drug.
Janssen sent a letter to health care providers and pharmacists about the voluntary recall of the syringes. The recall affects certain lots of the 234-milligram strength syringes. None of the other strengths of the antipsychotic drug are affected by the recall. The cracks are unnoticeable because the cracks are located under the label.
So far, there have not been any reports of leaks from the cracked syringes, infections, or negative effects since the launch of the prefilled Invega Sustenna syringes. The recall of the syringes is completely voluntary.
Invega Sustenna is related to the drug Risperdal, which along with other antipsychotic drugs has been linked to neuroleptic malignant syndrome (NMS). Both Risperdal and Invega are approved to treat symptoms of schizophrenia like catatonia, and Invega is marketed by Janssen in the United States.
Most of the inventory of the 234-milligram strength prefilled syringes are affected by the recall. Janssen expects to continue shipping syringes without cracks by early March. Normal product availability levels will be assumed by April.
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