FDA Recalls Test Cypionate/Propionate Injectable for Lack of Sterility Assurance
Carolina Infusion is recalling TEST CYP/PROP 100 MG/100 MG/ML injectable vials due to lack of assurance of product sterility. Patients should contact their healthcare provider.
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 a sterile injectable product where sterility cannot be assured—a risk-of-harm scenario. FDA Class II classification with no reported illnesses or injuries meets the High severity criterion per the rubric.
Plain-English summary
Carolina Infusion LLC is recalling TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable supplied in 12.6 mL vials. The recall is due to lack of assurance of sterility.
The affected lot is 07052022@1 with a beyond-use date of October 8, 2022. The product was distributed nationwide in the United States.
Patients who have used or possess affected lots should contact their healthcare provider immediately and discontinue use. Healthcare providers should report any adverse events to the FDA.
The recalled product
- Product
- TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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 (1)
- Lot: 07052022@1 BUD: 10/08/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Carolina Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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