January 26, 2018
A labeling error has prompted Premier Pharmacy Labs Inc. to recall mitomycin 40 mg/mL preservative-free irrigation 10-mL-single dose vial (NDC 69623-160-35), according to the January 24, 2018, US Food and Drug Administration (FDA) Enforcement Report. The compounded product is incorrectly labeled as mitomycin 40 mg/mL but contains mitomycin 40 mg/10 mL.
The recall affects lot MIT100217SVDS, which has a beyond-use date of March 1, 2018. Vials from the lot were distributed across the United States.
Premier Pharmacy Labs voluntarily initiated the recall January 11, 2018. At press time, the FDA had not yet classified the recall.
Mitomycin is an antineoplastic agent sometimes used for intravesical chemotherapy for bladder cancer.
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