Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure
Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.
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 with no reported illnesses or injuries. The hazard—lack of sterility assurance—is a theoretical risk rather than a confirmed contamination event. Per the rubric, theoretical hazards without reported illness are scored at most 3.
Plain-English summary
Northern VA Compounders PLLC, through Akina Pharmacy in Sterling, Virginia, is recalling Prostaglandin E1 Injection Solution (10 mcg/ml) packaged in 2.5 mL multiple-dose vials. Lot number 12012022@7 (expiration January 15, 2023) is affected.
The recall was issued because the manufacturer cannot assure the sterility of the compounded medication. Injectable products must be sterile to prevent contamination.
The affected vials were distributed nationwide. No illnesses or injuries have been reported.
Patients and healthcare providers with questions should contact Northern VA Compounders PLLC or their healthcare provider. Patients should not use medication from the recalled lot and should consult their physician about alternatives.
The recalled product
- Product
- Prostaglandin (E1) Injection Solution, 10 mcg/ml, 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
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- contamination-risk
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#: 12012022@7
- Exp 1/15/2023
Distribution
Distributed nationwide across the United States.
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