Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance
Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is 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 injectable medication lacking sterility assurance. No reported illnesses or injuries. Meets High severity as a risk-of-harm product with potential for serious infection, where injury has not yet been reported.
Plain-English summary
Northern VA Compounders PLLC is recalling QuadMix Super 002, a compounded injectable medication containing PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine (40mcg/30mg/4mg/0.4mg/mL). The product is packaged in 2.5 mL Multiple-Dose vials for prescription use. The affected lot number is 12062022@1 with an expiration date of 1/20/2023 and is distributed nationwide in the USA.
The recall was issued by the FDA as a Class II recall due to lack of assurance of sterility. The product did not meet the sterility standards required for injectable medications.
The recalled product
- Product
- QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/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
- Affected units
- 6
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#: 12062022@1
- Exp 1/20/2023
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
Same manufacturer · Northern VA Compounders PLLC
See all →- HighQuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-01-18
- HighTriMix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- HighTriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA (Drugs) · 2023-01-18
- HighCompounded Injectable Medication Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighInjectable Drug Recalled Over Failure to Assure Product Sterility
FDA (Drugs) · 2022-11-09
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09
- SevereQuad-Mix Injectable Compound Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- HighPharmacy Compounded Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- SevereSpecialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
- SevereQuad-Mix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17