Prostaglandin E1 Injection Vials Recalled for Sterility Issues
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact 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 an FDA Class II drug recall of a compounded injectable medication with lack of sterility assurance. This is a risk-of-harm product where injury has not yet been reported, fitting the Score 3 (High) criterion per the rubric.
Plain-English summary
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution, 40 mcg/ml, 2.5 mL multiple-dose vials compounded by Akina Pharmacy, Sterling, Virginia. The recall applies nationwide and was issued because the compounded product lacks assurance of sterility.
Sterility is critical for injectable medications. A lack of assurance of sterility in injectable products poses a significant risk of infection and other serious health consequences if the contaminated product is administered to patients.
The recalled lot is Lot# 12052022@11 with expiration date 1/19/2023. The recall involves 2 vials distributed nationwide. Patients or healthcare providers who have this product should not use it.
Patients currently using or who have received this product should contact their healthcare provider or pharmacist immediately. Healthcare providers should review their inventory, quarantine any remaining vials, and check whether any patients received this product.
The recalled product
- Product
- Prostaglandin (E1) Injection Solution, 40mcg/ml, 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
- infection-risk
- injectable-contamination
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#: 12052022@11
- Exp 1/19/2023
Distribution
Distributed nationwide across the United States.
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