QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 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 recall of an injectable medication with lack of assurance of sterility poses a risk of contamination and infection. No illnesses or injuries have been reported, so per rubric this falls under 'risk-of-harm products where injury has not yet been reported' = High severity.
Plain-English summary
QuadMix Plus is a compounded injectable medication containing PGE1, Papaverine HCl, Phentolamine Mesylate, and Atropine, manufactured by Northern VA Compounders PLLC (compounded by Akina Pharmacy in Sterling, Virginia). The product is distributed as 2.5 mL multiple-dose vials for prescription use.
Northern VA Compounders is recalling QuadMix Plus due to lack of assurance of sterility. The recall affects 78 vials that were distributed nationwide in the USA. The affected lots are: Lot 11182022@1 (expiration 1/2/2023), Lot 12012022@9 (expiration 1/15/2023), Lot 11142022@8 (expiration 12/29/2022), and Lot 11292022@10 (expiration 1/13/2023).
The recalled product
- Product
- QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/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
- 78
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 (8)
- Lot#: 11182022@1
- Exp 1/2/2023
- 12012022@9
- Exp 1/15/2023
- 11142022@8
- Exp 12/29/2022
- 11292022@10
- Exp 1/13/2023
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 →Related recalls
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