Agency classClass IIOur severity:High FDA (Drugs)·D-0123-2023·Announced 2023-01-18

TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns

FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.

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 no reported illnesses or injuries. The hazard is theoretical—lack of assured sterility rather than confirmed contamination—making this high-risk but not severe or critical per the rubric.

Plain-English summary

TriMix Plus 002 is a compounded injectable medication containing PGE1, Papaverine hydrochloride, and Phentolamine mesylate. It is manufactured by Northern VA Compounders PLLC and was compounded at Akina Pharmacy in Sterling, Virginia.

The FDA has initiated this recall because the compounding facility failed to provide assurance that the affected vials meet required sterility standards. Injectable medications must be sterile to prevent serious infections, as they bypass the body's natural defense mechanisms.

The recalled product was distributed nationwide. The affected lot is #12062022@4 with an expiration date of 1/20/2023, consisting of 36 vials of 2.5 mL each.

Consumers who received this medication should contact their healthcare provider immediately to discuss whether they may have received the recalled product and what appropriate follow-up care may be needed.

The recalled product

Product: TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/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 — Injectable / Compounded
Hazard: sterility-assurance
contamination
Affected units: 36

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#: 12062022@4
Exp 1/20/2023

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 →

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

Same hazard · sterility assurance