Compounded Testosterone Injection Recalled Due to Lack of Sterility Assurance

Plain-English summary

Tailor Made Compounding (TMC Acquisition LLC) is recalling 176 vials of Testosterone Cypionate/Propionate 180/20mg/ml, a compounded injectable medication. The recall affects two vial sizes: 5 mL-vials and 10 mL-vials packaged for room temperature storage. Affected batches include: 11042102A1 (expiration 4/30/2022), 12072135A1 (expiration 6/5/2022), 01142228A1 (expiration 7/13/2022), and 02182231A1 (expiration 8/17/2022).

The recall is due to lack of assurance of sterility. For injectable medications like testosterone, sterility assurance is critical because contaminated injectables can introduce serious infections.

The affected product was distributed nationwide throughout the United States and Puerto Rico. Patients and healthcare providers who received testosterone from these batches should consult with their prescribing healthcare provider about this recall.

Consumers should discontinue use of the affected product and contact their healthcare provider about alternative testosterone preparations. The FDA has classified this as a Class II recall.

The recalled product

Product

Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding

Manufacturer

TMC Acquisition LLC dba Tailor Made Compounding

Category

Drug — Injectable / Compounded

Hazard

• sterility-assurance
• contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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