FDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
Carolina Infusion, LLC is recalling Tri-MIX compounded syringes due to a lack of assurance of sterility related to formulation and processing equipment.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Carolina Infusion, LLC is recalling Tri-MIX (PAPAV/PHENTO/ALPROS), 30/2/40, packaged in single-use dosage syringes. The recall is due to a lack of assurance of sterility, which is related to the formulation using bacteriostic water and the processing equipment used in the compounded product.
The affected product is distributed nationwide within the U.S. The specific lots involved are 07282026@2 with a best use date of 9/11/2026, 08032026@11 with a best use date of 9/17/2026, and 08042026@3 with a best use date of 9/18/2026. The product quantity is 20 mLs in patient-specific syringe doses.
Patients and healthcare providers should stop using the affected syringes and contact their healthcare provider for further instructions. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Manufacturer
- Carolina Infusion, LLC
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 20
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)
- Lot: 07282026@2
- BUD: 9/11/2026
- 08032026@11
- BUD: 9/17/2026
- 08042026@3
- BUD: 9/18/2026. .
Distribution
Distributed nationwide across the United States.
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