Agency classClass IIOur severity:High FDA (Drugs)·D-0117-2023·Announced 2023-01-18

Injectable Compounded Drug Recall Due to Lack of Sterility Assurance

Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should consult their healthcare provider.

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 an injectable product with lack of sterility assurance. This is a risk-of-harm product where reported patient injury has not been documented, meeting the criteria for High severity.

Plain-English summary

TriMix Plus 001 is a compounded injectable medication in 2.5 mL multiple-dose vials. Each vial contains PGE1 (20 mcg), papaverine hydrochloride (30 mg), and phentolamine mesylate (2 mg). The product was manufactured by Northern VA Compounders PLLC (compounded by Akina Pharmacy in Sterling, Virginia) and distributed nationwide in the United States.

The recall involves 525 vials across two affected lots: Lot 11252022@5 with an expiration date of 1/9/2023, and Lot 12012022@12 with an expiration date of 1/15/2023.

The manufacturer initiated this recall due to lack of assurance of sterility. For injectable medications, maintaining sterility is critical to prevent contamination and ensure patient safety.

Patients who may have received an injection using this product should contact their healthcare provider. Healthcare providers and facilities should immediately discontinue use of the affected medication and properly dispose of any remaining vials from the identified lots.

The recalled product

Product: TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/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 — Injectable / Compounded
Hazard: sterility-failure
Affected units: 525

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#: 11252022@5
Exp 1/9/2023
12012022@12
Exp 1/15/2023

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