Franck's Lab Recalls Fluorouracil Sterile Ophthalmic and Injectable Solutions
Franck's Lab Inc. is recalling 14 units of sterile Fluorouracil products due to microbial contamination found in the clean room.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 sterile injectable and ophthalmic drugs with confirmed microbial contamination, posing a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of 14 units of sterile Fluorouracil (5-FU) products. The affected products include various ophthalmic solutions and injectable solutions in multiple concentrations and volumes. These products were distributed nationwide and to several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This finding indicates a lack of assurance of sterility for the products distributed between November 21, 2011, and May 21, 2012.
Patients and healthcare providers should stop using the affected products and contact their healthcare provider for further instructions. The specific prescription numbers associated with the recalled units are listed in the official recall documentation.
The recalled product
- Product
- FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION…
- Affected units
- 14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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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