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.

Recall Number: D-0251-2018

Firm: Premier Pharmacy Labs Inc

Classification: Class II

Status: Terminated

Report Date: 20180207

Initiation Date: 20180111

Termination Date: 20200604

Reason for Recall

Labeling: Label Error on Declared Strength

Product Description

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.