TriMix Injection Recalled Nationwide for Lack of Sterility Assurance
Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.
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 recall of a multiple-dose injectable with documented lack of sterility assurance. Although no illnesses or injuries have been reported, the product presents a risk of harm through potential infection. Per the severity rubric, unconfirmed hazards on high-risk products where injury has not yet been reported receive a High score.
Plain-English summary
Northern VA Compounders PLLC is recalling TriMix Injection (a compounded medication containing PGE1, Papaverine HCl, and Phentolamine) packaged in 2.5 mL multiple-dose vials due to lack of assurance of sterility. The recall affects 8 vials with the following lot numbers and expiration dates: Lot 11252022@15 (Exp 1/9/2023), Lot 11302022@9 (Exp 1/14/2023), and Lot 12022022@5 (Exp 1/16/2023). The product was compounded by Akina Pharmacy in Sterling, Virginia and distributed nationwide in the USA.
Patients who received doses from the recalled lots should contact their healthcare provider or pharmacy to determine if they received an affected dose. Healthcare providers should be consulted regarding alternative treatments or any necessary patient monitoring.
No illnesses or injuries have been reported in connection with this recall to date.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/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
- 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 (6)
- Lot#: 11252022@15
- Exp 1/9/2023
- 11302022@9
- Exp 1/14/2023
- 12022022@5
- Exp 1/16/2023
Distribution
Distributed nationwide across the United States.
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