Another injectables recall for Mylan

By Fiona BARRY contact

- Last updated on GMT

Related tags: Hypodermic needle

Another injectables recall for Mylan
Mylan has recalled 14 lots of calcium chloride intravenous infusion after customers found the prefilled syringes were not compatible with needless adaptors.

The affected batch – a 10% weight/volume solution packaged in 10ml syringes – was distributed in the US between March 2014 and February 2015 The product is labelled Amneal-Agila, which market the drug.

Mylan first issued a recall of some calcium chloride syringes in June, but issued a second notification when it realised some drug units may still be on the market.

Calcium Chloride IV infusion is used in resuscitation after cardiac arrest, and to treat low calcium levels, 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,​” said the US FDA.

The affected lots are:

National Drug Code

Name and Strength

Size

Lot #

Expiration

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7006979

April 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7006980

April 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7006981

April 2016

>53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7006990

April 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007007

May 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007008

May 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007009

May 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007010

May 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007063

June 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007064

June 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007065

June 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007066

June 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007109

July 2016

53150-697-01

Calcium Chloride Intravenous Infusion 10%w/v

10 mL

7007118

July 2016

Related topics: Markets & Regulations, Regulations

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