The FDA and Mylan ($MYL) have issued a reminder of the company's ongoing voluntary recalls for antibiotic and antiseizure drugs manufactured by Mylan's UDL Laboratories.
|A 500-mg Ciprofloxacin tablet--Courtesy of Mylan|
According to the most recent FDA Enforcement Report, Mylan issued recalls in 2013 for 11,650 cartons of Ciprofloxacin tablets and 3,993 cartons of Lamotrigine tablets. In both cases the drugs "were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices."
Both are Class II recalls. Lamotrigine is an antiseizure drug that is also used in the treatment of bipolar disorder. Ciprofloxacin is an antibiotic that is more widely known for use in treating exposure to anthrax.
Late last year, Novartis' ($NVS) generic division, Sandoz, recalled one lot of its generic version of AstraZeneca's ($AZN) blood pressure drug Atacand that was manufactured in India by Mylan. That was a Class III voluntary recall of 6,336 bottles of candesartan cilexetil that contained more impurities than specification allows. According to the FDA, the product was made by Mylan at a plant in Hyderabad, India.