Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Compounding Lab is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA 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 recall is classified as FDA Class II, and the presence of microorganisms and fungal growth in sterile injectable drugs poses a significant risk of serious injury or hospitalization due to 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 recall involves four different products: Testosterone Cyp/Estradiol Cyp 50mg/2mg/mL Injectable (5 mL), Testosterone Cypionate 50mg/mL Injectable (12 mL and 2.5 mL), and Testosterone Propionate 200mg/mL Injectable (10 mL). A total of 17 units were affected.
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 infection to patients using the products.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients who have received these products should contact their healthcare provider for guidance on discontinuing use and obtaining alternative treatment.
The recalled product
- Product
- TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML
- Category
- Drug — Sterile Injectable
- Affected units
- 17
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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