Compounded Injectable Drug Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medication due to lack of sterility assurance. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, classified as High (3).
Plain-English summary
BiMix STD 001 is a compounded injectable medication containing Papaverine HCl and Phentolamine Mesylate, manufactured by Northern VA Compounders PLLC and compounded by Akina Pharmacy in Sterling, Virginia. The recall involves 2.5 mL multiple-dose vials (Lot 10252022@3, expiration date 1/31/2023).
The FDA Class II recall was issued due to lack of assurance of sterility. The manufacturer cannot verify that the product was produced under the strict sterile conditions required for injectable medications.
The recalled product was distributed nationwide in the United States. Patients who have this medication should contact their healthcare provider or pharmacist.
The recalled product
- Product
- BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/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 — Compounded Injectable
- Hazard
- Affected units
- 1,200
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#: 10252022@3
- Exp 1/31/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Northern VA Compounders PLLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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