Agency classClass IIOur severity:High FDA (Drugs)·D-0122-2023·Announced 2023-01-18

BiMix Injection Recalled for Lack of Assurance of Sterility

Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots 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: This is an FDA Class II recall of a compounded injectable medication for lack of assurance of sterility. Sterility failures in injectable drugs pose a significant risk of serious infection. No illnesses or injuries have been reported in the source material, placing this in the High category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Northern VA Compounders PLLC has recalled BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL due to lack of assurance of sterility in the compounded injectable product. The recall affects 4 vials distributed nationwide, lot number 12062022@3, with expiration date 1/20/2023.

Lack of assurance of sterility in injectable medications poses a risk of microbial contamination, which could lead to serious infections if the product is administered. The product was compounded by Akina Pharmacy in Sterling, Virginia, and manufactured by Northern VA Compounders PLLC.

Patients who have received this medication or possess vials from the affected lot should immediately contact their healthcare provider or pharmacist. Do not use vials from lot 12062022@3. Healthcare providers and patients should report any adverse events related to the use of this product to the FDA.

The recalled product

Product: BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/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
Affected units: 4

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@3
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
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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