Agency classClass IIOur severity:High FDA (Drugs)·D-0107-2023·Announced 2023-01-18

Injectable Drug Recall: QuadMix Standard 001 Lacks Sterility Assurance

Northern VA Compounders recalls QuadMix Standard 001 injectable vials due to lack of sterility assurance. No illnesses reported.

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: This is an FDA Class II recall of an injectable drug due to lack of sterility assurance. While no illnesses have been reported and the hazard is theoretical, the potential for serious infection from non-sterile injectable medication makes this a High severity recall per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

QuadMix Standard 001 is an injectable compounded medication containing PGE1, Papaverine HCl, Phentolamine Mesylate, and Atropine, supplied in 2.5 mL multiple-dose vials. Northern VA Compounders PLLC is recalling 39 vials distributed nationwide due to lack of assurance of sterility.

The affected lots are: Lot #11162022@10 (expiration 12/31/2022) and Lot #12052022@9 (expiration 1/19/2023). The product was compounded by Akina Pharmacy located at 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Consumers and healthcare providers who have these vials should not use them and should contact their pharmacist or healthcare provider for guidance. Non-sterile injectable medications can pose serious health risks.

The recalled product

Product: QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Manufacturer: Northern VA Compounders PLLC
Category: Drug — Compounded Injectable
Hazard: sterility-failure
contamination-risk
Affected units: 39

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 (4)

Lot#: 11162022@10
Exp 12/31/2022
12052022@9
Exp 1/19/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by Northern VA Compounders PLLC 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 25 products in this recall →

Same manufacturer · Northern VA Compounders PLLC

See all →

High
QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
High
TriMix Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-01-18
High
TriMix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
High
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA (Drugs) · 2023-01-18
High
Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18

Same hazard · sterility failure