FDA Issues Reminder on Withdrawn Prefilled Syringes

FDA Issues Reminder on Withdrawn Prefilled Syringes
FDA Issues Reminder on Withdrawn Prefilled Syringes

The Food and Drug Administration (FDA) issued a reminder to quarantine and discontinue distribution of all affected lots of Mylan's Calcium Chloride Intravenous Infusion 10% w/v.

Mylan initially recalled 14 lots in April 2015 after customer complaints of difficulties in administration of the drug with an incompatibility between the syringe (10mL) and certain needleless adaptors. In emergency situations, this can possibly prohibit or delay the administration of the medication. In June 2015, Mylan issued a second notification of the market withdrawal. The affected lots were distributed in the United States between March 19, 2014 and February 24, 2015. The product is packaged with an Agila and Amneal label.

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The FDA recommends examining all inventory and crash boxes for any remaining lots of the affected product. Customers that have received the affected product should contact Stericycle (877) 598-5705 to obtain documentation for product return. Stericycle will also inform retail level customers that have received the affected lots.

Calcium Chloride Intravenous Infusion is used during the resuscitation procedure after a cardiac arrest and for the treatment of low calcium levels. It is also indicated for arrhythmias associated with hypocalcemia, hyperkalemia, or hypomagnesemia.

For more information call (877) 598-5705 or visit FDA.gov.

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