Class II · Moderate risk
Mitomycin Injection Solution
Lack of Assurance of Sterility
Mitomycin 0.02%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Affected NDC
70360-0005-35
Compare with the code on your package — it is the most precise check available.
Drug: Mitomycin
- Recalling firm
- Leiter's Compounding
- NDC code
- 70360-005-35
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0015-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mitomycin recalls
See all
Class II · Moderate risk
Mitomycin 0.4mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Mitomycin 0.2mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
MITOMYCIN INJECTION 0.375 mg/mL SYR
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Mitomycin-C
Lack of Assurance of Sterility
Other recalls by Leiter's Compounding
All 2016 recalls
Class II · Moderate risk
Vancomycin 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Placebo for Prednisolone Acetate 1%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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