The Recall Desk
HighFDA (Drugs)·D-0105-2023·Announced 2023-01-18

Injectable drug recalled due to lack of sterility assurance

Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.

What this means for you

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 a compounded injectable medication with lack of assurance of sterility. No illnesses or injuries have been reported. The lack of sterility assurance for injectable medications that enter the bloodstream directly represents a significant risk of harm from potential infection, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3).

Plain-English summary

QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine 40mcg/30mg/2mg/0.4mg/mL) is a compounded injectable medication in 2.5 mL multiple-dose vials. It was compounded by Akina Pharmacy in Sterling, Virginia and distributed by Northern VA Compounders PLLC.

Northern VA Compounders PLLC has initiated a nationwide recall of 56 vials (Lot #11162022@7, Expiration 12/31/2022) due to lack of assurance of sterility. The sterility of the injectable product cannot be confirmed to meet required safety standards.

Injectable medications must be sterile to prevent infection. For compounded drugs, the manufacturer must verify that the preparation process and controls ensure sterility. This recall indicates such verification could not be provided.

Patients who have received this product should consult their healthcare provider or pharmacist immediately. Healthcare providers should discontinue use of affected vials and contact patients who may have received doses from this lot.

The recalled product

Product
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/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 Injection
Hazard
  • lack-of-sterility
  • injection-contamination-risk

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#: 11162022@7
  • Exp 12/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category