Recall of Depo-Testosterone Injectable Due to Sterility Assurance Concerns
Franck's Lab Inc. is recalling Depo-Testosterone injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
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. According to the rubric, an FDA Class II recall involving a risk of harm (sterility failure in injectable drugs) where injury has not yet been reported corresponds to a severity score of 4 (Severe) or 3 (High). Given the direct risk of infection from non-sterile injectables, this is classified as Severe.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 9 units of Depo-Testosterone, MDV, 10ML 200MG/ML Injectable. The recall covers sterile human drugs distributed between November 21, 2011, and May 21, 2012.
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 finding indicates a lack of assurance of sterility for the affected products.
The affected units were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Specific prescription numbers associated with the recall include C0388707, C0393621, C0397891, C0397894, C0397896, C0397905, C0404812, C0405366, and C0407575. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 9
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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