Injectable drug recalled due to lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.
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 drug with lack of assurance of sterility. No illnesses or injuries are reported in the source. The hazard is theoretical but serious, as non-sterile injectables pose direct risk to patients. This meets the criteria for High (Score 3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carolina Infusion LLC is recalling TRI-MIX 30/2/40 Injectable, a 10 milliliter prescription injectable medication distributed nationwide in the United States. The recalled lots are: lot 07152022@4 with beyond-use date September 13, 2022, and lot 08152022@15 with beyond-use date October 14, 2022.
The recall was initiated because the manufacturer could not assure the sterility of the product. Sterile conditions are essential for injectable medications to ensure patient safety.
Patients or healthcare providers with the affected lots should stop using the medication and contact Carolina Infusion or their healthcare provider. Carolina Infusion's address is 95 Bees Creek Road, Ridgeland, SC 29936. The FDA classified this as a Class II recall.
The recalled product
- Product
- TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- infection-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 (4)
- Lots: 07152022@4
- BUD: 09/13/2022
- 08152022@15
- BUD: 10/14/2022
Distribution
Distributed nationwide across the United States.
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