The particulars may be different, but the outcome is the same for Fresenius Kabi, which is once again recalling one of its injectable drugs because of potential contamination with glass particles. This time, the injection in question is Benztropine Mesylate, four lots of which are being recalled.
According to a release, Fresenius has halted distribution of the product. Manufactured by Allergy Laboratories, the product is used to help treat all forms of Parkinsonism, a neurological condition most commonly caused by Parkinson's disease. Although the defect was classified as visible glass particulate, when glass splits apart into layers, it can also result in the formation of particles too small for the naked eye to see, the release says.
While "no adverse events, patient reactions or customer complaints" had been reported to the company at the time of the recall, the release notes that glass particles pose a number of potential safety risks, some of which, like the blockage of an artery, can be life-threatening.
Fresenius Kabi conducted a separate recall in late May, also for the risk of glass particles in vials. That recall, of one lot of Magnesium Sulfate Injection, came just one day after the FDA said it would turn to Fresenius for help relieving a drug shortage caused by glass particle contamination in a product from American Regent.
- read the release