Injectable testosterone product recalled for sterility assurance defect
Carolina Infusion is recalling TEST CYP 200 MG/ML Injectable due to the manufacturing process's inability to assure sterility. The affected lots were distributed nationwide; patients should not use the product.
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: No illnesses or injuries have been reported, and the hazard is the theoretical risk of contamination from inadequate sterility assurance rather than confirmed contamination. Per the rubric, this risk-of-harm scenario without reported injury qualifies as High severity.
Plain-English summary
Carolina Infusion LLC is recalling TEST CYP 200 MG/ML Injectable, a prescription injectable medication supplied in 10 ML vials. The recall affects two specific lots: Lot 06132022@5 with a best-by date of 09/11/2022, and Lot 08082022@17 with a best-by date of 11/06/2022. These lots were distributed nationwide throughout the United States.
The recall was issued because the manufacturing process cannot provide adequate assurance that the product meets sterility requirements. For injectable medications, sterility is a critical safety requirement, as any microbial contamination could result in serious infections.
Patients who have received injections from the affected lots should contact their healthcare provider for medical advice. Healthcare providers should not administer any remaining doses of the product from these recalled lots.
The recalled product
- Product
- TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Hazard
- sterility-defect
- 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 (2)
- Lots: 06132022@5 BUD: 09/11/2022
- 08082022@17 BUD: 11/06/2022
Distribution
Distributed nationwide across the United States.
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