Premier Pharmacy Labs Inc recalls Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercia…
- Recall date
- January 11, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0251-2018
- FDA classification
- Class II
- Brand / firm
- Premier Pharmacy Labs Inc
- Sold / distributed
- Nationwide.
Why it was recalled
Labeling: Label Error on Declared Strength
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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