Compounded QuadMix injectable recalled for sterility assurance concerns
Northern VA Compounders PLLC recalled QuadMix Injectable nationwide due to lack of assurance of sterility. Patients who received this compounded medication should contact their healthcare provider immediately.
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 of a compounded injectable with documented sterility assurance failure. Although no illnesses or injuries are reported in the source material, injectable drugs with sterility concerns pose significant risk of serious infection or sepsis in patients, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
QuadMix Injectable, a compounded medication containing PGE1, Papaverine HCl, Phentolamine Mesylate, and Atropine, has been recalled by Northern VA Compounders PLLC. The product consists of 2.5 mL multiple-dose vials (Lot #11292022@12, expiring 1/13/2023) distributed nationwide in the United States.
The recall was issued because the manufacturer could not assure sterility of the product. Compounded injectable medications must meet rigorous sterility standards to prevent microbial contamination, which could cause serious infections in patients.
Patients who have received this medication should contact their healthcare provider immediately to determine whether they may have been affected and to discuss appropriate next steps. Healthcare providers should verify lot numbers for affected patients and consider clinical follow-up as needed.
The recalled product
- Product
- QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 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
- Affected units
- 2
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#: 11292022@12
- Exp 1/13/2023
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.
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