TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.
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 is an FDA Class II compounded injectable drug recall for lack of assured sterility. Although no illnesses or injuries have been reported, the theoretical hazard of compromised sterility in injectable medications carries significant risk of harm. Per the rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Northern VA Compounders PLLC is recalling TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate 11.8mcg/18mg/0.6mg/mL), a prescription injectable medication packaged in 2.5 mL multiple-dose vials. The recall is due to lack of assurance of sterility. The affected vials were compounded by Akina Pharmacy (Sterling, VA). Lot #11262022@8 (expiring 1/10/2023) and Lot #11302022@12 (expiring 1/14/2023) are included in this recall, with 8 vials distributed nationwide.
Sterility is essential for injectable medications. The manufacturer cannot assure that the compounded product is sterile. Patients who received this product should immediately contact their healthcare provider.
Do not use any remaining vials from the affected lots. Healthcare providers should notify affected patients and discuss alternative treatment options.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/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-failure
- injection-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 (4)
- Lot#: 11262022@8
- Exp 1/10/2023
- 11302022@12
- Exp 1/14/2023
Distribution
Distributed nationwide across the United States.
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