Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
What this means for you
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 recalls involving injectable products warrant heightened concern due to infection risk. However, no illnesses or injuries are reported in the source material, and the hazard is theoretical sterility assurance rather than confirmed contamination, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
QuadMix Injectable, a compounded medication containing PGE1, Papaverine HCl, Phentolamine Mesylate, and Atropine, is being recalled by Northern VA Compounders PLLC due to lack of assurance of sterility. The medication is supplied in 2.5 mL multiple-dose vials.
The recall applies to Lot #12082022@8 with expiration date 1/22/2023 and was distributed nationwide. This is an FDA Class II recall.
Consumers and healthcare providers who have this medication should not use it and should contact Northern VA Compounders PLLC or the dispensing pharmacy for return instructions. Those who have used this product and have health concerns should contact their healthcare provider.
The recalled product
- Product
- QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/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-risk
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#: 12082022@8
- Exp 1/22/2023
Distribution
Distributed nationwide across the United States.
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