Medications & Supplements/Prescription Drugs

Akina Pharmacy Compounded Injectable Drugs Recalled for Sterility Concerns

Agency Publication Date: January 12, 2023

Summary

Northern VA Compounders PLLC (operating as Akina Pharmacy) has recalled approximately 2,862 vials of several compounded injectable drugs, including QuadMix, TriMix, BiMix, Mitomycin, Prostaglandin (E1), and Methylcobalamin. These medications were recalled because they may not be sterile. No illnesses or injuries have been reported to date. These products were packaged in 2 mL, 2.5 mL, and 10 mL multiple-dose vials and distributed nationwide throughout the United States.

Risk

If an injectable drug is not sterile, it can cause serious infections at the injection site or in the bloodstream. For patients with weakened immune systems, these infections can be particularly dangerous or life-threatening.

What You Should Do

This recall affects various compounded injectable drugs sold under the Akina Pharmacy name, including specific doses of QuadMix, TriMix, BiMix, Mitomycin, Prostaglandin (E1), and Methylcobalamin.
Check your medication vials for lot numbers such as 12082022@8, 10252022@3, 11212022@8, 12062022@3, 12062022@7, and 11182022@1. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Northern VA Compounders PLLC at 23475 Rock Haven Way, Suite 105, Sterling, VA 20166 for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12082022@8 (Exp 1/22/2023)

Compounded by Akina Pharmacy

Product: BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

10252022@3 (Exp 1/31/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11212022@8 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@3 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: Mitomycin Injection Solution, 4mg/ml

Variants: 10 mL Multiple-Dose vial

Lot Numbers:

12062022@7 (Exp 1/20/2023)

12072022@32 (Exp 1/22/2023)

Compounded by Akina Pharmacy

Product: TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@4 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11182022@1 (Exp 1/2/2023)

12012022@9 (Exp 1/15/2023)

11142022@8 (Exp 12/29/2022)

11292022@10 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12012022@11 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11162022@7 (Exp 12/31/2022)

Compounded by Akina Pharmacy

Product: TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@17 (Exp 12/29/2022)

11262022@7 (Exp 1/10/2023)

12022022@3 (Exp 1/16/2023)

Compounded by Akina Pharmacy

Product: QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11162022@10 (Exp 12/31/2022)

12052022@9 (Exp 1/19/2023)

Compounded by Akina Pharmacy

Product: QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@1 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 10 mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

12012022@7 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 20 mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

11212022@5 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 25mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

11252022@12 (Exp 1/9/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 40mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

12052022@11 (Exp 1/19/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@12 (Exp 12/29/2022)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@11 (Exp 12/29/2022)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11182022@2 (Exp 1/2/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11212022@7 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11252022@5 (Exp 1/9/2023)

12012022@12 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11262022@8 (Exp 1/10/2023)

11302022@12 (Exp 1/14/2023)

Compounded by Akina Pharmacy

Product: Methylcobalamin Injection Solution, 12.5mg/ml

Variants: 2 mL Multiple-Dose vials

Lot Numbers:

11292022@16 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11292022@12 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11252022@15 (Exp 1/9/2023)

11302022@9 (Exp 1/14/2023)

12022022@5 (Exp 1/16/2023)

Compounded by Akina Pharmacy

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91443

Status: Resolved

Manufacturer: Northern VA Compounders PLLC

Sold By: Akina Pharmacy

Manufactured In: United States

Units Affected: 25 products (2 vials; 78 vials; 12 vials; 56 vials; 750 vials; 39 vials; 6 vials; 4 vials; 4 vials; 108 vials; 2 vials; 2 vials; 4 vials; 2 vials; 4 vials; 525 vials; 8 vials; 2 vials; 2 vials; 8 vials; 4 vials; 36 vials; 2 vials; 1200 vials; 2 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various compounded injectable drugs sold under the Akina Pharmacy name, including specific doses of QuadMix, TriMix, BiMix, Mitomycin, Prostaglandin (E1), and Methylcobalamin.

Check your medication vials for lot numbers such as 12082022@8, 10252022@3, 11212022@8, 12062022@3, 12062022@7, and 11182022@1. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Northern VA Compounders PLLC at 23475 Rock Haven Way, Suite 105, Sterling, VA 20166 for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12082022@8 (Exp 1/22/2023)

Compounded by Akina Pharmacy

Product: BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

10252022@3 (Exp 1/31/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11212022@8 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@3 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: Mitomycin Injection Solution, 4mg/ml

Variants: 10 mL Multiple-Dose vial

Lot Numbers:

12062022@7 (Exp 1/20/2023)

12072022@32 (Exp 1/22/2023)

Compounded by Akina Pharmacy

Product: TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@4 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11182022@1 (Exp 1/2/2023)

12012022@9 (Exp 1/15/2023)

11142022@8 (Exp 12/29/2022)

11292022@10 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12012022@11 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11162022@7 (Exp 12/31/2022)

Compounded by Akina Pharmacy

Product: TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@17 (Exp 12/29/2022)

11262022@7 (Exp 1/10/2023)

12022022@3 (Exp 1/16/2023)

Compounded by Akina Pharmacy

Product: QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11162022@10 (Exp 12/31/2022)

12052022@9 (Exp 1/19/2023)

Compounded by Akina Pharmacy

Product: QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

12062022@1 (Exp 1/20/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 10 mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

12012022@7 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 20 mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

11212022@5 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 25mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

11252022@12 (Exp 1/9/2023)

Compounded by Akina Pharmacy

Product: Prostaglandin (E1) Injection Solution, 40mcg/ml

Variants: 2.5 mL Multiple-Dose vials

Lot Numbers:

12052022@11 (Exp 1/19/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@12 (Exp 12/29/2022)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11142022@11 (Exp 12/29/2022)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11182022@2 (Exp 1/2/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11212022@7 (Exp 1/5/2023)

Compounded by Akina Pharmacy

Product: TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11252022@5 (Exp 1/9/2023)

12012022@12 (Exp 1/15/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11262022@8 (Exp 1/10/2023)

11302022@12 (Exp 1/14/2023)

Compounded by Akina Pharmacy

Product: Methylcobalamin Injection Solution, 12.5mg/ml

Variants: 2 mL Multiple-Dose vials

Lot Numbers:

11292022@16 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11292022@12 (Exp 1/13/2023)

Compounded by Akina Pharmacy

Product: TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL

Variants: 2.5 mL Multiple-Dose vials, Injectable

Lot Numbers:

11252022@15 (Exp 1/9/2023)

11302022@9 (Exp 1/14/2023)

12022022@5 (Exp 1/16/2023)

Compounded by Akina Pharmacy

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91443

Status: Resolved

Manufacturer: Northern VA Compounders PLLC

Sold By: Akina Pharmacy

Manufactured In: United States

Distributed To: Nationwide