German generics unit Fresenius Kabi issued two separate voluntary recalls for injectables produced at its plant in Illinois.
A Class II recall was put out by the company and posted on the FDA’s enforcement page for more than 96,000 units of the muscle relaxant cisatracurium besylate that are administered intravenously. The firm found the product had an incorrect statement of “preservative free” on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
A Class III recall was issued for more than 48,000 units of the antipsychotic injectable drug haloperidol decanoate in 50 milligram doses due to an impurity out-of-specification result.
Both drugs are prescription-only products.
Back in 2012 and 2013, the generics maker had a spate of FDA warning letters for plants in Grand Island, NY, Kalyani, India, and Puerto Rico. It upgraded its plant in New York.
- access the FDA posting here