Franck's Lab Recalls Sterile Mitomycin Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile Mitomycin/Lidocaine/Epinephrine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific products involved are Mitomycin/Lidocaine/Epinephrine 0.04%/0.02%/0.1% Injectable 5 ML and Mitomycin/Lidocaine/Epinephrine 0.08MG/13.3MG/6.7MCG/ML Injectable 0.2 ML. The recall covers 7 units of these products.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility poses a risk to patients who receive these injections.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients and healthcare providers should stop using these products and contact their healthcare provider for further instructions.
The recalled product
- Product
- MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #'s: 0399208 0385915
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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