Quality & complianceOfficial

Carolina Infusion recalls compounded quad-mix injectable over lack of sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

FDA's enforcement report lists a Class II recall of Carolina Infusion's papaverine, phentolamine, alprostadil and trimix-style injectable, citing processing equipment concerns; the recall is ongoing nationwide.

The US Food and Drug Administration has published a Class II recall of QUAD-MIX (PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, a compounded product made by Carolina Infusion, LLC. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0021-2027.

The stated reason is a lack of assurance of sterility. The enforcement report links this to the processing equipment used in making the compounded product.

The recall is listed as ongoing, and the product was distributed nationwide within the United States. The text available for this item does not include lot numbers, quantities, expiry dates or details of any adverse events, so the scope of affected batches cannot be confirmed from it.

For context, FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Compounders and outsourcing facilities should note that sterility-assurance recalls can trace back to equipment used in processing, not only to the formulation itself.
  • Pharmacy, clinic and distribution customers of Carolina Infusion should check the full FDA enforcement report entry for lot and code details before acting on stock.
  • Pharmacovigilance and quality teams should watch for updates, as the recall remains ongoing and the public text gives no scope or event data.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →