Class II · Moderate risk
Mitomycin Injection Solution
Lack of Assurance of Sterility
*Mitomycin 0.04% Ophth DR eye drops
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Affected NDC
67457-0518-05
Compare with the code on your package — it is the most precise check available.
Drug: Mitomycin Category: Eye Drops & Ophthalmic
- Recalling firm
- Medical Center Pharmacy, Inc.
- NDC code
- 67457-0518-05
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1077-2020 · 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 Medical Center Pharmacy, Inc.
All 2020 recalls
Class II · Moderate risk
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
*Morphine 2 mg/mL Cassette
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Vancomycin Opthal 14 mg drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Albumin Eye Drop 10% S
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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