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.
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 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
- Affected units
- 2
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.
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.
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