Testosterone Cypionate Injectable Vials Recalled Due to Sterility Assurance Concerns
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials 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: This is an FDA Class II recall of an injectable medication. Although no illnesses or injuries have been reported, lack of assurance of sterility in injectable drugs poses a serious risk of infection or contamination to patients.
Plain-English summary
TMC Acquisition LLC, operating as Tailor Made Compounding, is recalling Testosterone Cypionate (GSO) 100mg/ml injectable solution in 1mL and 2mL vials. The recall is due to lack of assurance of sterility.
The recall involves 273 vials from multiple batches: 12212109A2 (exp. 6/19/2022), 01312217A1 (exp. 7/30/2022), 10202108A1 (exp. 4/18/2022), 12012125A (exp. 5/30/2022), 02182230A1 (exp. 8/17/2022), and 03022222A1 (exp. 8/29/2022). The product has been distributed nationwide in the USA and Puerto Rico.
Patients and healthcare providers in possession of affected vials should not use the product. Consult with the manufacturer or your healthcare provider regarding safe disposal and replacement options.
The recalled product
- Product
- Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination
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 (13)
- Batch#: a) 12212109A2
- Exp 6/19/2022
- 01312217A1
- Exp 7/30/2022
- b) 10202108A1
- Exp 4/18/2022
- 12012125A
- Exp 5/30/2022
- 02182230A1
- Exp 8/17/2022
- 10202108A1
- 03022222A1
- Exp 8/29/2022.
Distribution
Distributed nationwide across the United States.
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