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.

FDA recall notice · announced February 7, 2018 · Premier Pharmacy Labs

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Labeling: Label Error on Declared Strength

Notes

Distribution: Nationwide.
Lot/code information: Lot: MIT100217SVDS BUD: 03/01/2018
Quantity: 193 vials
Status: Terminated
Products in this recall event:
- 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. (D-0251-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.