Recalls / Class II
Class IID-0251-2018
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.
- Affected lot / code info
- Lot: MIT100217SVDS BUD: 03/01/2018
Why it was recalled
Labeling: Label Error on Declared Strength
Recalling firm
- Firm
- Premier Pharmacy Labs Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8265 Commercial Way, Weeki Wachee, Florida 34613-4511
Distribution
- Quantity
- 193 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-01-11
- FDA classified
- 2018-02-02
- Posted by FDA
- 2018-02-07
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0251-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.