Compounded Testosterone Injection Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable medication with lack of sterility assurance, representing a significant risk of serious infection. No illnesses or deaths are reported in the source, making this a theoretical risk-of-harm situation that meets the High severity threshold.
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.
Lot numbers (10)
- Batch#: a)11042102A1
- Exp 4/30/2022
- 12072135A1
- Exp 6/5/2022
- 01142228A1
- Exp 7/13/2022
- 02182231A1
- Exp 8/17/2022
- b)11042102A1
- Exp 7/13/2022.
Distribution
Distributed nationwide across the United States.
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