Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs containing methylprednisolone and lidocaine because environmental 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 significant risk of serious injury or hospitalization due to potential infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall involves three specific products: Methylprednisolone Acetate/Lidocaine HCl 40mg/10mg/ml Injectable (100 ml and 500 ml) and Methylprednisolone/Lidocaine 80mg/10mg/ml Injectable (24 ml).
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 receiving the injections.
The affected products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients who received these injections should contact their healthcare provider for evaluation. The specific prescription numbers associated with the recall are 0408599, 0401410, and 0402367.
The recalled product
- Product
- METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML; METHYLPREDNISOLONE/LIDOCAINE 80MG/10MG/ML INJECTABLE 24 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 4
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: 0408599 0401410 0402367
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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