Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.
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 compounded injectable medication lacking sterility assurance presents significant risk of infection if administered. No illnesses or confirmed contamination have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Northern VA Compounders PLLC is recalling QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine 10mcg/30mg/2mg/0.2mg/mL), a compounded injectable medication packaged in 2.5 mL multiple-dose vials. The recall was initiated because the manufacturer cannot assure the sterility of the product in the affected lot.
The recall applies to lot #12012022@11, with an expiration date of January 15, 2023. A total of 12 vials were distributed nationwide in the United States. This medication is compounded by Akina Pharmacy in Sterling, Virginia and is a prescription-only product.
Patients should not use this medication if they have a vial from the recalled lot. They should contact their healthcare provider or pharmacist for guidance on obtaining replacement medication if needed. Healthcare providers and pharmacies should identify and quarantine the affected lot immediately.
The recalled product
- Product
- QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/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 — Compounded Injectable
- Affected units
- 12
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#: 12012022@11
- 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.
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