CLASS II Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Mitomycin 40 mg/mL Preservative Free Irrigation Volume recalled
Premier Pharmacy Labs is recalling Mitomycin 40 mg/mL Preservative Free Irrigation Volume: SDV , Compounded by: Premier, distributed nationwide in the US. The recall was initiated on 11 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0251-2018
- FDA event ID
- 78928
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2018
- FDA classified
- 2 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Compounded Drugs
Timeline
| 11 Jan 2018 | Recall initiated by company | |
| 2 Feb 2018 | Classified by FDA | +22 days |
| 7 Feb 2018 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength
Product as listed by the FDA
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.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength
Which lots are affected?
Lot: MIT100217SVDS BUD: 03/01/2018
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Premier Pharmacy Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Sterile Injectable Solution *Contains recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
Other Mitomycin recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mitomycin 0.2mg/ML Droptainer) Oph Solution recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin 0.4mg/ML Droptainer) Oph Solution recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Injection Solution, 4mg/ml recalled | Northern VA Compounders Pllc | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Mitomycin 10 MG / Ivp Syringe recalled by Infusion Options | Infusion Options | Sterility | NY |