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FDA MedWatch - Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

AUDIENCE: Critical Care Medicine, Nursing

ISSUE: 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. FDA has recently become aware that some units of this drug may still be on the market. Please check your inventory and crash boxes, quarantine and discontinue distribution and use of affected lots (see press release below for list of affected lots).

BACKGROUND: 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.

RECOMMENDATION:
• Immediately examine your inventory and crash boxes, quarantine and discontinue distribution and use of these lots.
•If you have the affected product, please contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
•In addition, if you have further distributed the affected product, please identify your customers and notify them at once of this market withdrawal. The customer should be instructed to contact Stericycle at 1-877-598-5705 to obtain the documentation packet for return of product.
•Additionally, Stericyle will notify your retail level customers that received the affected lots. Provide a list of customers via Microsoft Excel file to mylan5322@stericycle.com within 10 business days.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
•Complete and submit the report Online: www.fda.gov/MedWatch/report
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm454836.htm


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