TriMix Injection Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.
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 an injectable medication with lack of sterility assurance. Non-sterile injectables represent a significant risk of harm through potential serious infection, making this a risk-of-harm product. No illnesses have been reported, placing this at the High severity level per the rubric.
Plain-English summary
TriMix Injection is a compounded prescription injectable medication containing PGE1, Papaverine HCl, and Phentolamine Mesylate in 2.5 mL multiple-dose vials. The affected product was compounded by Akina Pharmacy in Sterling, Virginia, and is manufactured by Northern VA Compounders PLLC. Lot number 11142022@12, which expires 12/29/2022, has been distributed nationwide.
This recall was issued due to lack of assurance of sterility. The FDA has determined that the sterility of the product cannot be assured through the manufacturing process.
Patients who have received or are currently using this product should contact their healthcare provider or pharmacy immediately. Do not use the product. Your healthcare provider can discuss appropriate follow-up care and alternative treatment options if needed.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/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 — Injectable / Compounded
- 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#: 11142022@12
- Exp 12/29/2022
Distribution
Distributed nationwide across the United States.
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