Carolina Infusion Injectable Hormones Recalled Due to Sterility Concerns
Carolina Infusion is recalling TEST CYP/DHEA injectable hormone products due to lack of sterility assurance. The recall affects nationwide distribution of 3 ML and 6 ML vials.
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 for lack of sterility assurance in an injectable product represents a risk-of-harm situation with no reported illnesses or injuries, meeting the High severity criterion.
Plain-English summary
Carolina Infusion LLC is recalling TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML injectable hormone products in 3 ML and 6 ML vials due to lack of assurance of sterility. The affected product lots are 07182022@9 (with an expiration date of 10/16/2022) and 07272022@15 (with an expiration date of 10/25/2022).
The FDA classified this as a Class II recall because the company cannot ensure the product meets sterility requirements. This injectable product is distributed nationwide as a prescription-only medication.
If you have received this product, consult with your healthcare provider immediately. Do not use these specific lots. Healthcare providers should remove affected inventory from stock and contact patients who may have received the affected product. The manufacturer is located at 95 Bees Creek Road, Ridgeland, SC 29936.
The recalled product
- Product
- TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable / Hormone
- Hazard
- lack-of-sterility
- 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 (2)
- Lots: 07182022@9 BUD: 10/16/2022
- 07272022@15 BUD: 10/25/2022
Distribution
Distributed nationwide across the United States.
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