Reported Feb 7, 2018 · Terminated
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265…
Premier Pharmacy Labs Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Premier Pharmacy Labs Inc · 8265 Commercial Way · Weeki Wachee, FL · 34613-4511
Is this the product you have?
- Mitomycin 40 mg/mL
- Preservative Free Irrigation Volume10 mL SDV
- Compounded by
Premier Pharmacy Labs 8265 Commercial WayWeeki WacheeFL 34613
- NDC69623-160-35
- Lot codes and dates
- LotMIT100217SVDS
- BUD03/01/2018
- Amount recalled
- 193 vials
Where it was sold
- Nationwide
Why it was recalled
Labeling: Label Error on Declared Strength
This product could cause temporary or reversible health problems — stop using it.
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