Class II U.S. Food and Drug Administration

Carolina Infusion, LLC Tri-MIX ,30/1/60, injectable recall: Lack of Assurance of Sterility: Related to processing equipment used

Recall published 11 days ago

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

The hazard

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Recall details

Recall number
D-0025-2027
Published
October 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Carolina Infusion, LLC
Product type
Prescription & OTC drugs
Units affected
5 mL in patient specific syringe dose
Distribution
Nationwide
Made in
United States
Lot / code info
Lot:08062026@10, BUD: 9/20/2026.

Products covered by this recall

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

What to do if you are taking this medicine

Do not stop a prescription on your own. A recalled drug is usually still safer than an untreated condition, and your pharmacist can swap the lot the same day.

  1. Compare the lot number and expiry date on your bottle or carton with the codes listed above. Only those lots are recalled.
  2. Keep taking the medicine until you have spoken to your prescriber or pharmacist, unless the notice above says to stop immediately. Abruptly stopping some drugs is more dangerous than the defect itself.
  3. Call the pharmacy that dispensed it. They can see which lot they gave you and will normally replace it from unaffected stock at no charge.
  4. Report any side effect you think the product caused to the FDA MedWatch programme at fda.gov/medwatch — that reporting is what triggers most drug recalls in the first place.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs you nothing.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price; keep the receipt the pharmacy issues for the return.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue — recall claims are handled separately.
  • If the recall voided a prescription you had already paid for in full, your insurer will normally re-authorise a replacement fill ahead of schedule. Mention the recall number when you call.

Company contact: Carolina Infusion, LLC — 95 Bees Creek Rd, Ridgeland, SC, 29936-7540

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

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