Injectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/60 Injectable (5 ML vials) nationwide due to lack of assured sterility. The affected lots have Beyond Use Dates in August and September 2022. Contact your healthcare provider if you received this 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: This FDA Class II recall involves an injectable medication with lack of sterility assurance. No illnesses or injuries have been reported in the source text. The hazard represents a risk of serious harm (infection, sepsis) from potential contamination, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carolina Infusion LLC is recalling TRI-MIX 30/1/60 Injectable, 5 ML vials, nationwide due to lack of assurance of sterility. Three specific lots are affected, with Beyond Use Dates of August 30, 2022; September 17, 2022; and September 20, 2022. The product was distributed across the United States.
Injectable medications must maintain strict sterility standards to prevent serious infections. The lack of assured sterility means this product cannot be guaranteed to be free from contamination.
If you have received this medication, contact your healthcare provider immediately. Do not use any vials from the recalled lots. Healthcare providers and patients should follow appropriate clinical guidance regarding potential exposure.
The recalled product
- Product
- TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- Manufacturer
- Carolina Infusion
- Affected units
- 3
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 (6)
- Lots: 07012022@6
- BUD: 09/20/2022
- 07192022@16
- BUD: 09/17/2022
- 07012022@4
- BUD: 08/30/2022
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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