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Thursday, 15 October 2015 00:00

Market Withdrawal Of Calcium Chloride Intravenous Infusion 10% W/V 10ml Prefilled Syringe

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The Agency has been informed by FDA of the market withdrawal of 14 Lots of Calcium chloride intravenous infusion 10% w/v prefilled syringe by Mylan Institutional.

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. 

Reason for Recall:

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.

Possible Associated Risk:

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.A delay in treatment may potentially lead to patient injury or death.

Product details

  • Manufacturer: Agila Specialties Private Limited, a Mylan company located in Bangalore, India. The 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.
  • Specification:  All lots which have the NDC code 53150-697-01. The withdrawn lots are as follows:

Lot No.

Expires

7006979

April 2016

7006980

April 2016

7006981

April 2016

7006990

April 2016

7007007

May 2016

7007008

May 2016

7007009

May 2016

7007010

May 2016

7007063

June 2016

7007064

June 2016

7007065

June 2016

7007066

June 2016

7007109

July 2016

7007118

July 2016

  • We therefore recommend that healthcare providers should take note of these affected batches, immediately discontinue use and quarantine the withdrawn products. You are further encouraged to report adverse events or side effects related to the use of the above mentioned products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or via the undersigned email: This email address is being protected from spambots. You need JavaScript enabled to view it.
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