Mylan arm recalls India-made 81,086 vials of Haloperidol Decanoate injection

Mylan Institutional LLC, a subsidiary of the US-based Mylan Inc, has recalled India-made 81,086 vials of Haloperidol Decanoate injection used in the US and Puerto Rico. The drug is indicated for the treatment of schizophrenic patients who require prolonged parenteral anti-psychotic therapy.

In two separate notification, the US Food and Drug Administration (FDA) said the company has made a voluntary recall of 11,030 cartons (55,150 vials) of 100 mg/ml and 2,523 cartons (25,936 vials) of 50 mg/ml Haloperidol Decanoate injection for intra mascular use only with 1 ml single dose vials packaged in cartons of five and ten, respectively. The drugs were manufactured in India for Mylan Institutional LLC, Illinois.

The ongoing recall was initiated on February 18, 2015 and has been classified as a Class II recall. While 100 mg lots were scheduled to expire in April 2016, the 50 mg batches had an expiry date of July 2016. The reason of the recall has been given as lack of assurance of sterility due to leaking vials.

Class II recall is 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.

Last month, the company also recalled two more drugs manufactured in India.

In one notification by US FDA, it said that Mylan recalled 936 vials of the cancer treatment doxorubicin hydrochloride injection, USP, 200 mg/100 mL (2 mg/mL) which was manufactured in India by Bangalore-based by Onco Therapies and distributed by Amneal-Agila, LLC, Glasgow, Kentucky for use in the United States.

The reason behind the Class III recall was given as mispack of correct labeled product where a correctly labeled vial of chemotherapy drug Ifosfamide injection 50 mg/mL, 60 mL was mispackaged in a carton of doxorubicin hydrochloride injection. The recall of the drug lot which was initiated on February 11, 2015 had an expiry of April 2015.

In another notification, the US regulator said Mylan has voluntarily recalled 78,090 vials of the blood pressure medicine nicardipine hydrochloride injection which were manufactured in India. The recall was initiated on January 23, 2015 because the drugs were subpotent drug and they failed impurities/degradation specifications. It was also a Class III recall with the expiry date on the batches were given as February 2015 for two lots and April 2015 for the other four lots.

In case of Class III recall, use of or exposure to a violative product is not likely to cause adverse health consequences.