Compounded Testosterone Enanthate Injectables Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (5 mL and 10 mL) due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
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 pharmaceutical recall for lack of sterility assurance on a compounded injectable product. No reported illnesses or injuries are stated in the source material, qualifying this as score 3 (High) per the rubric: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (both 5 mL and 10 mL vial configurations) due to lack of assurance of sterility. The recall affects compounded injectable medications distributed nationwide in the United States and Puerto Rico.
The affected product includes the following batch numbers: 5 mL vials (Batch 10142117A2 expiring 4/12/2022; 10272108A1 expiring 4/25/2022; 11302113A2 expiring 5/29/2022; 02252220A1 expiring 8/24/2022) and 10 mL vials (Batch 10142108A2 expiring 4/12/2022; 12072134A1 expiring 6/5/2022).
Individuals who have received this product should consult with their healthcare provider about potential risks and alternative treatment options.
The recalled product
- Product
- Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- 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 (11)
- Batch#: a)10142117A2
- Exp 4/12/2022
- 10272108A1
- Exp 4/25/2022
- 11302113A2
- Exp 5/29/2022
- 02252220A1
- Exp 8/24/2022
- b)10142108A2
- 12072134A1
- Exp 6/5/2022.
Distribution
Distributed nationwide across the United States.
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