Franck's Lab Recalls Sterile Tetracosactide Acetate Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile Tetracosactide Acetate injectables 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 involves a sterile injectable drug contaminated with microorganisms and fungal growth, which poses a significant risk of serious injury or 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 specific product identified in this notice is Tetracosactide Acetate (Cosyntropin) 0.25mg/ml Injectable, 1 mL. The recall covers 6 units associated with specific prescription numbers.
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 finding indicates a lack of assurance of sterility for the affected products.
The affected products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 6
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: 0387998 0391766 0398634 0400173 0400383 0402841
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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