TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
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 no reported illnesses or injuries. The hazard is theoretical—lack of assured sterility rather than confirmed contamination—making this high-risk but not severe or critical per the rubric.
Plain-English summary
TriMix Plus 002 is a compounded injectable medication containing PGE1, Papaverine hydrochloride, and Phentolamine mesylate. It is manufactured by Northern VA Compounders PLLC and was compounded at Akina Pharmacy in Sterling, Virginia.
The FDA has initiated this recall because the compounding facility failed to provide assurance that the affected vials meet required sterility standards. Injectable medications must be sterile to prevent serious infections, as they bypass the body's natural defense mechanisms.
The recalled product was distributed nationwide. The affected lot is #12062022@4 with an expiration date of 1/20/2023, consisting of 36 vials of 2.5 mL each.
Consumers who received this medication should contact their healthcare provider immediately to discuss whether they may have received the recalled product and what appropriate follow-up care may be needed.
The recalled product
- Product
- TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/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 — Injectable / Compounded
- Hazard
- sterility-assurance
- contamination
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#: 12062022@4
- Exp 1/20/2023
Distribution
Distributed nationwide across the United States.
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