Drug Mislabeled as Preservative-Free Recalled by Fresenius Kabi
The manufacturer is including about 95,000 vials in its recall
A drug manufacturer has announced a recall for a mislabeled product.
Fresenius Kabi USA is recalling its Cisatracurium Besylate Injection, 20 mg per 10 mL, a skeletal muscle relaxant. The packaging of the product claims that it is preservative-free. However, 0.9 percent benzyl alcohol has been added as a preservative.
The product is designed for use as an IV injection. The packaging bears National Drug Code number 63323-417-10, lot number 6010157, and expiration date 01/01/2017.
About 95,000 vials of the product are included in the recall.
The company distributed the affected items nationwide.
The Food and Drug Administration considers this action to be a Class II recall, meaning that exposure to this product may cause temporary or medically reversible adverse health consequences. The risk of a serious health issue is small.
Consumers with questions about this recall can contact Fresenius Kabi at (888) 386-1300.