Mylan put the word out in April that healthcare providers that had any of the 10-mL prefilled syringes of calcium chloride infusion from 14 specific lots manufactured for Amneal needed to return them. In June, it sent out a reminder of the recall. This week, Mylan again asked providers to check their storerooms and crash boxes after learning some of the syringes are still being used.
The problem, Mylan ($MYL) explains, is that the calcium chloride products are considered lifesavers, injected as part of the resuscitation procedure following a cardiac arrest and for treating arrhythmias. There have been complaints of difficulties giving the drug because of incompatibility between the syringe and certain needleless adaptors.
The prefilled syringes were made by its Agila unit for Swiss drug company Amneal, and they have labels that bear both names, Mylan said. They were distributed in the U.S. between March 19, 2014, and February 24 of this year.
Mylan has had to deal with a number of voluntary recalls in recent months of products made by Agila, the sterile injectable drug operation for which it shelled out $1.7 billion to India's Strides Arcolab in 2013. Last month, it expanded a voluntary recall of about 15 lots of cancer drugs, some manufactured for Pfizer ($PFE), after finding particulate in retained samples. Last year, it retrieved 10 lots of the injectable "hypnotic drug" etomidate it manufactured for Pfizer because some of the cartons and vials were missing shipping labels. Black particulate was also found in some vials that was identified as coming from shredded labels.
- here's the recall reminder