Check Pharmacy Inventory for Withdrawn Calcium Chloride Injection

Mylan is urging health care professionals to check their inventories for certain lots of calcium chloride intravenous infusion prefilled syringes that were withdrawn from the market in April.

The company initiated the voluntary market withdrawal of 14 product lots after receiving complaints from customers that the syringe was not compatible with certain needleless adaptors.

Because calcium chloride intravenous infusion 10%w/v in 10-mL prefilled syringes is used in emergency situations as a life-saving drug, difficulties in administrating it could create a potential risk, Mylan noted.

The affected lots of the product were distributed in the United States between March 19, 2014, and February 24, 2015, and packaged with an Agila and Amneal label.

Since Mylan recently learned that some affected units could still be on the market, including the pharmacy and clinic level, the company is asking health care professionals to check their inventory and crash boxes for the following lots:

Health care professionals who locate a listed product should stop its distribution and use, and then contact Stericycle at 1-877-598-5705 to obtain the documentation packet for its return. If a listed product was distributed further, Mylan suggests identifying those customers and notifying them of the market withdrawal.

Stericyle will notify retail-level customers who received the affected lots on behalf of those who provide a list of customers via Microsoft Excel file to mylan5322@stericycle.com within 10 business days.

Any adverse reactions related to use of the withdrawn product should be reported to FDA’s MedWatch Adverse Event Reporting program.