Carolina Infusion product recalled over sterility concerns
- Recall date
- August 26, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Carolina Infusion recalls 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 Cre…
- Recall number
- D-1523-2022
- FDA classification
- Class II
- Brand / firm
- Carolina Infusion
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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