Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
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 a Class II FDA recall of a compounded injectable drug due to lack of sterility assurance. While no illnesses, hospitalizations, or injuries are reported, injectable products without assured sterility present significant infection risk and meet the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Northern VA Compounders PLLC is recalling TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL injectable compounded by Akina Pharmacy in Sterling, Virginia. The recall affects 750 vials distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The manufacturer cannot confirm that the product meets required sterility standards for injectable medications.
The affected lots are: Lot #11142022@17 (expiration 12/29/2022), Lot #11262022@7 (expiration 1/10/2023), and Lot #12022022@3 (expiration 1/16/2023).
Patients currently using this medication should discontinue use immediately and consult their healthcare provider about alternative treatment options. Healthcare providers should retrieve and dispose of any remaining vials of the affected lots.
The recalled product
- Product
- TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/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-assurance
- 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 (6)
- Lot#: 11142022@17
- Exp 12/29/2022
- 11262022@7
- Exp 1/10/2023
- 12022022@3
- Exp 1/16/2023
Distribution
Distributed nationwide across the United States.
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