FDA recall D-0251-2018
Premier Pharmacy Labs Inc · Class II · drug
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
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2018-01-11
- Report date
- 2018-02-07
- Termination date
- 2020-06-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Weeki Wachee, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2018