Mylan Calcium Choride Injection Recall Issued Over Syringe Problems

Following additional reports of problems with prefilled calcium chloride syringes, Mylan has re-announced a market withdrawal for 14 lots of injections where the syringe and needleless adaptors may not be compatible, potentially resulting in delays in treatment that could be life-threatening. Despite a prior recall, some of the syringes appear to still be on the market. 

The Calcium Chloride Intravenous Infusion 10% w/v recall was originally announced in April 2015, due to a risk that consumers may suffer serious and potentially life-threatening heart complications caused by low calcium levels due to the incompatibility.

Mylan Institutional issued a second notification of the market withdrawal in June 2015, but FDA re-announced the recall on July 13, after becoming aware that some units of this drug may still be available on the market and in consumer’s inventories.

The Calcium Chloride Intravenous Infusions 10% w/v syringes are used as part of the resuscitation procedure for individuals following a cardiac arrest and for the treatment of low calcium levels and for treating arrhythmias associated with hypocalcaemia, hyperkalemia and hypomagnesaemia. The prefilled syringes are intended to be used in emergency situations to resuscitate and stabilize individuals.

Due to the products use as a lifesaving drug and device, any difficulty or delay in the administration process could increase injury risks including death.

The recall includes 10mL Calcium Chloride Intravenous Infusion 10%w/v products with lot numbers 7006979, 7006980, 7006981, 7006990, 7007007, 7007008, 7007009, 7007010, 7007063, 7007064, 7007065, 7007066, 7007109, and 7007118. The products were distributed for sale at the pharmacy and clinic levels across the U.S from March 19, 2014 through February 24, 2015. The products were manufactured by Mylan Institutional and packaged with an Agila and Amneal label, who are marketing partners for the Calcium Chloride product.

The FDA is asking customers to check their inventory, quarantine, and discontinue distribution and use of these particular lot codes. Customers should then contact Stericycle at 1-877-598-5705 to obtain a documentation packet for return to be issued a credit or check for reimbursement.