Agency classClass IIOur severity:High FDA (Drugs)·D-1533-2022·Announced 2022-09-21

FDA Recalls Injectable Medication Due to Sterility Assurance Failure

Carolina Infusion's QUAD-MIX 30/2/60/0.15 injectable (Lot 08022022@12) is recalled nationwide because the manufacturer failed to assure sterility. Patients and healthcare providers should not use affected vials and should contact the manufacturer.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for injectable drug with failure to assure sterility; no illnesses or injuries reported, but non-sterile injectables pose high risk of infection and represent a risk-of-harm product.

Plain-English summary

QUAD-MIX 30/2/60/0.15 Injectable is a prescription medication supplied in 5 mL vials by Carolina Infusion LLC, located in Ridgeland, South Carolina. The recall covers Lot 08022022@12, which had a Beyond Use Date of October 1, 2022.

The U.S. Food and Drug Administration has classified this as a Class II recall due to the manufacturer's failure to assure that the affected vials meet sterility standards. Sterile injectable medications must be free from contamination and must meet established manufacturing controls for patient safety.

The affected product was distributed nationwide. Patients and healthcare providers who have received or administered QUAD-MIX from the recalled lot should contact Carolina Infusion LLC immediately. Patients should not use vials from this lot and should consult their healthcare provider about any concerns or symptoms following use.

The recalled product

Product: QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable / Pharmaceutical
Hazard: lack-of-sterility
Affected units: 1

Is your product affected?

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

Lot numbers (2)

Lot: 08022022@12
BUD: 10/01/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Carolina Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Same manufacturer · Carolina Infusion

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