FDA recalls injectable compounded mixture in single-use syringes

Plain-English summary

The U.S. Food and Drug Administration is recalling QUAD-MIX (PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, packaged in single-use dosage syringes, distributed nationwide within the United States by Carolina Infusion LLC. The recall is related to a lack of assurance of sterility associated with processing equipment used in the compounding of this product. The affected lot number is LOT 08032026@24, with a batch expiration date of 09/17/2026. Consumers who have received this product should not use it and should contact Carolina Infusion, LLC for further instructions.

No illnesses, injuries, or deaths have been reported in connection with this recall. The FDA classified this recall as Class II, meaning that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers are advised to follow any return or disposal instructions provided by the manufacturer or the FDA.

This recall affects patients who received this compounded injectable product from Carolina Infusion LLC. The product was distributed nationwide within the United States. Affected consumers should take appropriate action as directed by the recall notice and the manufacturer.

The recalled product

Product

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

Manufacturer

Carolina Infusion, LLC

Category

Medical Device — Compounded Injectable

Hazard

• sterility

Affected units

5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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