The FDA has decided that Fresenius Kabi’s retrieval of more than 200,000 syringes rises to the level of a Class I recall. The recall comes at a sensitive time for the generic sterile injectables company, which also recently received an FDA warning letter for a plant that makes cancer drugs.
The recall was initiated in early November but was only classified last week by the FDA. Fresenius is recalling to the hospital level a single lot that contains 203,136 prefilled, single-use syringes in blister packs labeled as Midazolam Injection. The individual syringes actually contain, and are labeled as, Ondansetron Injection.
Midazolam is a sedative that is used to relax patients before surgeries or medical procedures, while Ondansetron treats nausea and vomiting.
While no injuries have been reported, the company pointed out in a notice that not only can a missed dose of midazolam lead to ineffective sedation, but it is possible a patient might inadvertently receive an additional dose of ondansetron, which can cause arrhythmias in some patients. Fresenius said patients may also be at risk for serotonin syndrome, which in some cases have been fatal.
Last month, the FDA issued a warning letter to a Fresenius oncology API plant in Kalyani, Nadia, West Bengal, which cited the facility for some repeat violations. The plant had received an earlier warning letter in 2013.
The new problems with the FDA come even as the drugmaker is making massive investments in its manufacturing capabilities in the U.S. to gain a bigger piece of the U.S. generic market. That includes its $4.75 billion buyout of U.S.-based generics maker Akorn.