Franck's Lab Recalls Sterile Injectable Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling 32 units of sterile injectable magnesium products distributed between November 2011 and May 2012 because environmental sampling found microorganisms and fungal growth 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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 32 units of sterile human drugs. The affected products include various concentrations and volumes of Magnesium Chloride, Magnesium Sulfate, and Magnesium Sulfate in Dextrose injectables. These products were distributed nationwide and to several international locations, including the Bahamas, Colombia, 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.
Healthcare providers and patients should discontinue use of these specific products and contact the recalling firm or their healthcare provider for further instructions. The recall covers 14 different product configurations identified by specific prescription numbers.
The recalled product
- Product
- MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML…
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 32
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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