Injectable Drug Recall: QuadMix Standard 001 Lacks Sterility Assurance
Northern VA Compounders recalls QuadMix Standard 001 injectable vials due to lack of sterility assurance. No illnesses reported.
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: This is an FDA Class II recall of an injectable drug due to lack of sterility assurance. While no illnesses have been reported and the hazard is theoretical, the potential for serious infection from non-sterile injectable medication makes this a High severity recall per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
QuadMix Standard 001 is an injectable compounded medication containing PGE1, Papaverine HCl, Phentolamine Mesylate, and Atropine, supplied in 2.5 mL multiple-dose vials. Northern VA Compounders PLLC is recalling 39 vials distributed nationwide due to lack of assurance of sterility.
The affected lots are: Lot #11162022@10 (expiration 12/31/2022) and Lot #12052022@9 (expiration 1/19/2023). The product was compounded by Akina Pharmacy located at 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Consumers and healthcare providers who have these vials should not use them and should contact their pharmacist or healthcare provider for guidance. Non-sterile injectable medications can pose serious health risks.
The recalled product
- Product
- QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/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
- Hazard
- sterility-failure
- 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 (4)
- Lot#: 11162022@10
- Exp 12/31/2022
- 12052022@9
- Exp 1/19/2023
Distribution
Distributed nationwide across the United States.
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