Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV Recalled by Premier Pharmacy Labs Inc Due to Labeling: Label Error on Declared Strength
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Premier Pharmacy Labs Inc directly.
Affected Products
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.
Quantity: 193 vials
Why Was This Recalled?
Labeling: Label Error on Declared Strength
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Premier Pharmacy Labs Inc
Premier Pharmacy Labs Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report