Another injectables recall for Mylan
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 |
