TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.
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: This is an FDA Class II recall with no reported hospitalizations or illnesses. The recall involves a risk-of-harm product (compounded injectable) where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
Northern VA Compounders PLLC is recalling TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate), a compounded injectable medication supplied in 2.5 mL multiple-dose vials. The affected lot is #11212022@7, with an expiration date of January 5, 2023. A total of four vials of this prescription medication were distributed nationwide.
The recall was initiated due to lack of assurance that the product meets required sterility standards for injectable medications. Non-sterile injectables could pose a risk of infection or other complications if administered to patients.
The affected product was distributed nationwide to healthcare providers and pharmacies. Patients and healthcare providers who have this medication should contact their pharmacy or healthcare provider.
All remaining vials from Lot #11212022@7 should be returned to the pharmacy or manufacturer immediately and not used. Patients who have received injections from this lot should consult with their healthcare provider regarding any health concerns.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/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
- 4
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#: 11212022@7
- Exp 1/5/2023
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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