Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling four sterile injectable drug products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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 sterile injectable drugs 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 four sterile injectable drug products: FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML, and FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML. The recall covers 12 units of these products.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility affects all sterile human drugs distributed by the company between November 21, 2011, and May 21, 2012.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Specific prescription numbers associated with the recall include 0357028, 0372461, 0374296, 0376008, 0397681, 0407302, 0392293, 0371718, and 0396669. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Injectable
- Affected units
- 12
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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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