Franck's Lab Recalls Sterile Verapamil Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Verapamil HCL injectable drugs distributed between November 2011 and May 2012 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 microbial and fungal contamination of sterile injectable drugs, which poses a significant risk of serious injury or infection.
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 recall includes six different products of Verapamil HCL injectable in various concentrations and volumes. The products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
The recall was initiated after FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This indicates a lack of assurance of sterility for the affected products.
Patients and healthcare providers should stop using the recalled products and contact their healthcare provider for guidance. The recall covers specific prescription numbers: 0405155, 0401813, 0405492, 0397906, 0401484, 0401488, 0401490, and 0395651.
The recalled product
- Product
- VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML INJECTABLE 20 MLS 40 ML 50 ML 50 MLS (6 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drugs
- Affected units
- 8
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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