FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used in compounding raised concerns about the product's sterility.
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 due to a lack of assurance of sterility in the compounded injectable product. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Carolina Infusion, LLC is recalling Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, an injectable medication packaged in single-use dosage syringes. The recall was initiated due to a lack of assurance of sterility related to the processing equipment used in the compounded product.
The affected product is identified by Lot 08062026@10 with a beyond-use date of 9/20/2026. The product was distributed nationwide within the United States. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Patients who have received this medication should contact their healthcare provider for guidance. The source text does not provide specific consumer instructions beyond the general recall notice.
The recalled product
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, 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 — Injectable
- Hazard
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)
- Lot:08062026@10
- BUD: 9/20/2026.
Distribution
Distributed nationwide across the United States.
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