FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion QUAD-MIX injectable recalled for sterility assurance issue
What this means
Carolina Infusion, LLC is recalling QUAD-MIX injectable medication (a compounded injection containing papaverine, phentolamine, alprostadil, and tropicamide) due to concerns about sterility. The issue stems from processing equipment used to prepare the product. The affected lot is 08032026@24, with a Beyond Use Date of 09/17/2026.
- If you have received this medication, contact your healthcare provider immediately.
- Do not use the product if you have it.
- Return the medication to the pharmacy or prescriber for safe disposal.
- Ask your provider about alternative treatment options.
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
5 mls in patient specific syringe doses
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0021-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
- FDA-Drug2026-10-14Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
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