Mylan Issues Reminder on Previous Withdrawal of Certain Lots of CaCl Prefilled SyringesBy
Mylan has issued a reminder regarding its previously announced voluntary market withdrawal of 14 lots of calcium chloride intravenous infusion 10% w/v, packaged in 10-mL prefilled syringes. In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of calcium chloride intravenous infusion 10% w/v, packaged in 10-mL prefilled syringes. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. The company said it has recently become aware that some units of this drug may still be on the market and advises discontinuation of distribution and use of these lots.
The market withdrawal was initiated as a precautionary measure due to the receipt of customer complaints citing difficulties in administration of the drug as a result of incompatibility between the syringe and certain needleless adaptors. 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.
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. Because of the use of calcium chloride intravenous infusion prefilled syringes in emergency situations, and its use as a lifesaving drug, difficulty in the administration of the drug could create a potential risk by prohibiting or delaying the administration of the medication.