German drugmaker Fresenius Kabi's U.S. operation has completed the recall of half a million vials of drugs started more than two years ago because the glass had fractures and might have contained particles.
According to the most recent FDA Enforcement Report, the company's APP Pharmaceuticals in September 2012 initiated the voluntary recall of one lot each of three drugs, which amounted to 101,200 vials of midazolam hydrochloride injection, a sedative; 184,550 vials of antinausea drug ondansetron injection and 240,550 vials of cyanocobalamin injection for B-12 deficiencies. All three were recalled due to a lack of assurance of sterility because of fractures in the vials. The Dec. 17 FDA Enforcement Reports say the recalls have been terminated.
It was in 2012 that APP's Grand Island, NY, plant received a warning with a list of issues, including failures to document "major defects" in drug lots, including vials found to contain particles of foreign matter. According to the Form 483, released by the FDA, for 18 months the company didn't get around to doing an "Initial Impact Assessment" on more than 400 consumer complaints about drugs made at the plant, including heparin. The complaints, received from January 2010 until inspectors arrived in June 2011, included everything from patient reactions to hair and insects found in vials.
Inspectors also said the plant had inadequate written procedures for preventing bacterial contamination and for ensuring that its drugs conformed to strength, purity and quality standards. At the time, the company said it was working with the FDA to remedy the issues. The FDA has not yet issued a closeout letter for the plant.
Since then, Fresenius has received a warning letter for its oncolytic API plant in Kalyani, India. The company closed down the plant in January 2013 when inspectors outlined the problems, then restarted production that July after making "significant progress in fixing them."
- the Enforcement Report notices are here, here and here