 "Medical device")
Aurobindo Pharma arm AuroMedics Pharma LLC is recalling 59.5 thousand vials of antipsychotic Fluphenazine Decanoate injection USP 125mg/5mL, (5 mL multiple dose vial) from the US market, the USFDA said.
AuroMedics Pharma LLC is recalling 59,500 vials of the injection on account of "Discoloration; hazy solution found in one vial instead of a clear solution," the US heath regulator said in its latest Enforcement Report.
The product was distributed to major wholesalers/distributors who may have further distributed the product throughout the US, it added.
The voluntary ongoing recall is a class II recall, the United States Food and Drug Administration (USFDA) said.
As per the regulator, class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
Fluphenazine Decanoate Injection, USP is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (for example chronic schizophrenics).
