TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials 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: This compounded injectable drug cannot assure sterility, representing a risk-of-harm product under FDA Class II classification. No illnesses or injuries are reported in the source material, so per the rubric, this scores at 3 (High).
Plain-English summary
TriMix Injection is a compounded prescription injectable medication containing PGE1, Papaverine HCl, and Phentolamine Mesylate (10mcg/20mg/1mg/mL). The affected product is packaged in 2.5 mL multiple-dose vials and was compounded by Akina Pharmacy in Sterling, Virginia.
Northern VA Compounders PLLC initiated this recall because the firm cannot assure that the product meets sterility standards required for injectable medications. Compounded injectable drugs must be sterile to be safe for use. The recall was issued by the Food and Drug Administration as a Class II recall.
The affected product is TriMix Injection Lot #11212022@8 with an expiration date of 1/5/2023. Two vials of this lot were distributed nationwide. Patients who have received this product should contact their healthcare provider or pharmacist to determine whether the medication was used. Unused medication from the recalled lot should not be used.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/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 — Compounded Injectable
- Hazard
- sterility-concern
- infection-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#: 11212022@8
- Exp 1/5/2023
Distribution
Distributed nationwide across the United States.
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