The Recall Desk
HighFDA (Drugs)·D-0115-2023·Announced 2023-01-18

TriMix Injectable Medication Recalled for Lack of Sterility Assurance

Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.

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 a compounded injectable with lack of sterility assurance. No reported illnesses or injuries are mentioned in the source; the hazard is theoretical. This meets the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Northern VA Compounders PLLC is recalling TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate 60mcg/30mg/3mg/mL), supplied in 2.5 mL multiple-dose vials. The affected lot (11182022@2, expiration January 2, 2023) was distributed nationwide in the United States.

The recall is due to lack of assurance of sterility. This is an FDA Class II recall.

Patients who have received this medication should not use the affected vials and should contact their healthcare provider immediately for guidance on their medical care and treatment options.

The recalled product

Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 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
  • lack-of-sterility

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#: 11182022@2
  • Exp 1/2/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category