Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone 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 the hazard involves a lack of assurance of sterility in injectable drugs, which carries a risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of seven different sterile injectable drug products. These products contain combinations of bupivacaine, lidocaine, and methylprednisolone in various concentrations and volumes, including 15 ml, 18.75 ml, 26.25 ml, 37.5 ml, 45 ml, 450 ml, and 900 ml vials.
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 lack of assurance of sterility poses a risk of infection to patients who receive these injections. The affected products were distributed nationwide and internationally to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies between November 21, 2011, and May 21, 2012.
Healthcare providers and patients should stop using these products immediately. The specific prescription numbers associated with the recalled lots are 0383652, 0383653, and 0383651. Consumers and healthcare professionals should contact the recalling firm or their healthcare provider for further instructions on how to handle or dispose of the recalled medication.
The recalled product
- Product
- BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 7
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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