Injectable Compounded Drug Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should 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: FDA Class II recall of an injectable product with lack of sterility assurance. This is a risk-of-harm product where reported patient injury has not been documented, meeting the criteria for High severity.
Plain-English summary
TriMix Plus 001 is a compounded injectable medication in 2.5 mL multiple-dose vials. Each vial contains PGE1 (20 mcg), papaverine hydrochloride (30 mg), and phentolamine mesylate (2 mg). The product was manufactured by Northern VA Compounders PLLC (compounded by Akina Pharmacy in Sterling, Virginia) and distributed nationwide in the United States.
The recall involves 525 vials across two affected lots: Lot 11252022@5 with an expiration date of 1/9/2023, and Lot 12012022@12 with an expiration date of 1/15/2023.
The manufacturer initiated this recall due to lack of assurance of sterility. For injectable medications, maintaining sterility is critical to prevent contamination and ensure patient safety.
Patients who may have received an injection using this product should contact their healthcare provider. Healthcare providers and facilities should immediately discontinue use of the affected medication and properly dispose of any remaining vials from the identified lots.
The recalled product
- Product
- TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 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-failure
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#: 11252022@5
- Exp 1/9/2023
- 12012022@12
- Exp 1/15/2023
Distribution
Distributed nationwide across the United States.
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