Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after 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 contamination of sterile injectable drugs, which carries a significant risk of serious injury or hospitalization if administered.
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 includes 24 units of various sterile injectable products, such as Sodium Bicarbonate and Sodium Chloride solutions, in multiple volumes.
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 contamination to the products.
The affected 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. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0
- Category
- Drug — Sterile Injectables
- Affected units
- 24
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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