FDA-Drug2018-02-07Class II
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Premier Pharmacy Labs Inc
Hazard
Labeling: Label Error on Declared Strength
Sold states
Nationwide.
Affected count
193 vials
Manufactured in
8265 Commercial Way, Weeki Wachee, FL, United States
Products
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2018Don't want to check this manually?
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