FDAnews
www.fdanews.com/articles/172222-mylan-lengthens-calcium-chloride-syringes-recall

Mylan Lengthens Calcium Chloride Syringes Recall

July 21, 2015

Mylan is continuing its recall of 14 lots of calcium chloride prefilled syringes that are incompatible with certain needleless adaptors, issuing a second letter in June after learning the product may still be on the market.

The recall began in April after customers complained of difficulties administering the drug. The lots involved were manufactured in India and distributed in the U.S. between March 2014 and February 2015, and are packaged with an Amneal-Agila LLC label.

The ongoing recall is the latest in a series of recalls involving products produced at Mylan facilities in India. In June, the company expanded its recall of injectable gemcitabine and methotrexate because of foreign matter detected during quality control tests.

Earlier this year, the company recalled two injectables, a hypertension drug over impurities and degradation and cancer treatment due to mispackaging. Both drugs were manufactured in India.

View the recall notice at www.fdanews.com/07-16-15-mylanrecall.pdf. — John Bechtel