Mylan’s Withdrawn Difficult-to-Administer Prefilled Syringe Still on Market, Sparks FDA Concern

July 15, 2015
BioPharm International Editors

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

In April 2015, Mylan issued a voluntary market withdrawal of 14 lots of calcium chloride intravenous infusion 10% w/v, packaged in 10 mL prefilled syringes due to difficulties in administration. The company issued a second notification of the market withdrawal in June 2015. FDA reported that some units of this drug could still be on the market and has advised healthcare professionals to examine their inventory and crash boxes. Affected lots should be quarantined and distribution discontinued.

The product was withdrawn as a precautionary measure following complaints of difficulties administering the drug as a result of incompatibility between the syringe and certain needleless adaptors. Calcium chloride intravenous infusion 10% w/v is used in emergency situations and any difficulty in administering the product has the potential risk of hindering or delaying the administration of the life-saving medication.

Calcium chloride intravenous infusion 10% w/v is used as part of the resuscitation procedure following a cardiac arrest and for the treatment of low calcium levels. It is also used for arrhythmias associated with hypocalcaemia, hyperkalaemia or hypomagnesaemia.

The lots involved with this market withdrawal were distributed in the United States between March 19, 2014, and February 24, 2015. The calcium chloride product is packaged with an Agila and Amneal label. Amneal is a marketing partner with Agila for calcium chloride intravenous infusion 10%w/v, 10 mL prefilled syringes.

Source: FDA