Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in… was recalled on September 10, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded 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
Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .
Units affected: 20 mLs - in patient specific syringe dose
Where it was sold: Nationwide within the U.S
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Carolina Infusion, LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
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