The Recall Desk
HighFDA (Drugs)·D-0108-2023·Announced 2023-01-18

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.

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 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
Hazard
  • lack-of-sterility
  • 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#: 12062022@1
  • Exp 1/20/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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