Agency classClass IIOur severity:High FDA (Drugs)·D-1534-2022·Announced 2022-09-21

FDA Recalls QUAD-MIX Injectable for Sterility Assurance Failure

Carolina Infusion recalls QUAD-MIX injectable (Lot 08082022@3) nationwide due to lack of sterility assurance, a critical safety requirement for injectable medications.

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 classification without reported hospitalizations or illnesses. Sterility assurance failure in injectable medications represents a high-risk product defect with potential for serious infection, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Carolina Infusion LLC is recalling QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable due to a lack of assurance of sterility. The affected lot is 08082022@3, with a beyond-use date of October 7, 2022. The product was distributed nationwide in the United States.

QUAD-MIX is a prescription-only injectable medication. Sterility assurance is required for all injectable medications to prevent infections and serious health complications. This recall addresses a failure to ensure the affected lot meets required sterility standards.

The recalled product

Product: QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Manufacturer: Carolina Infusion
Category: Drug — Injectable
Hazard: sterility-failure
infection-risk
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: 08082022@3
BUD: 10/07/2022

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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