Official recall notice

FDA DrugClass IINotable

Tri-MIX /40 Recall (Oct 2026) – Carolina Infusion

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

Recall date
2026-10-14
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

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Product description

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Affected products

Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .

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