Testosterone injectable drug recall due to lack of sterility assurance
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
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 injectable pharmaceutical products with lack of assurance of sterility. Compounded injectable products lacking sterility assurance are risk-of-harm products, meeting the High severity criterion.
Plain-English summary
Tailor Made Compounding, operating under TMC Acquisition LLC, has recalled Testosterone Cypionate/Enanthate 100/100mg/ml injectable products. The recall involves 58 vials available in 2 mL, 4 mL, and 10 mL sizes with the following batch numbers and expiration dates: 01142227A1 (expires 7/13/2022), 12012126A2 (expires 5/30/2022), 02042203A1 (expires 8/3/2022), and 01052207A1 (expires 7/4/2022).
The recall was issued due to lack of assurance of sterility. These compounded injectable products must meet strict sterility standards to ensure patient safety.
The affected products were distributed nationwide throughout the United States and to Puerto Rico.
The recalled product
- Product
- Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- 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 (8)
- Batch#: Expiry: a) 01142227A1
- Exp 7/13/2022
- b) 12012126A2
- Exp 5/30/2022
- 02042203A1
- Exp 8/3/2022
- c) 01052207A1
- Exp 7/4/2022.
Distribution
Distributed nationwide across the United States.
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