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FDAClass II

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes… Recalled: Lack of Assurance of Sterility: Related to processing equipment used in compounded produc…

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged… was recalled on September 10, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility: Related to processing equipment used in compounded product..

Is my unit affected?

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, 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,

Model, lot & date codes to check

Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.

Units affected: 15 mLs - in patient specific syringe doses

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.

What's the hazard?

Lack of Assurance of Sterility: 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.

Your remedy & how to claim it

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.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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