TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
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 pharmaceutical product due to sterility assurance failure. No illnesses or injuries have been reported; the hazard represents a theoretical contamination risk from process failure rather than confirmed harm, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Northern VA Compounders PLLC is recalling TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL injectable solution in 2.5 mL multiple-dose vials. The recalled lot is 11142022@11, which expires 12/29/2022.
The product is being recalled due to a lack of assurance of sterility. The recalled product was distributed nationwide in the United States. Four vials were involved in this recall.
Patients who have received this product should contact their healthcare provider. Healthcare providers should stop dispensing the recalled product and contact Northern VA Compounders PLLC for return instructions.
The recalled product
- Product
- TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/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-assurance-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 (2)
- Lot#: 11142022@11
- Exp 12/29/2022
Distribution
Distributed nationwide across the United States.
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