NOV 08, 2017
Due to a labeling error, Fresenius Kabi USA is voluntarily recalling lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL. The product was sold to wholesale distributors in the United States between May 12 and October 18, 2017.
Midazolam (Verced) is a sedative used to treat anxiety or induce general anesthesia before medical procedures. A single carton (NDC 76045-001-20, product code 766120) contains 24 blister packs, each enclosing a 2-mL prefilled single-use glass syringe.
The blister packs in the recalled lot are mislabeled as Midazolam Injection, USP, 2 mg/2 mL, but the syringes contain — and are correctly labeled as — Ondansetron Injection, USP, 4 mg/2 mL. Ondansetron (Zofran) is an unrelated medication used to treat the nausea and vomiting associated with chemotherapy or surgical procedures.
No injuries have been reported thus far, according to the FDA. However, midazolam and ondansetron syringes bear close resemblance to each other, and inadvertently swapping these medications could have dire consequences.
Physicians and patients can report adverse reactions or quality issues by 2 methods:
Online: Report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting.
Mail or fax: Download the reporting form or call 1-800-332-1088 to request one, and then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.