Prostaglandin Injectable Recalled Nationwide Due to Sterility Assurance Concerns
Northern VA Compounders PLLC is recalling a compounded Prostaglandin (E1) Injection due to lack of sterility assurance. Patients should consult their healthcare provider immediately.
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 for a compounded injectable with lack of sterility assurance presents a risk of harm to patients, but no illnesses or injuries have been reported in the source text. This fits the rubric category of 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Northern VA Compounders PLLC is recalling Prostaglandin (E1) Injection Solution, 20 mcg/ml, supplied in 2.5 mL multiple-dose vials, compounded by Akina Pharmacy located in Sterling, Virginia. The affected lot (11212022@5) expired 1/5/2023.
The recall is issued because the manufacturer cannot assure that the product meets sterility requirements for injectable medications. Lack of sterility assurance presents a risk of contamination in products administered directly into the body.
The affected lot was distributed nationwide in the United States. Patients who received injections from this lot should contact their healthcare provider immediately for guidance.
Do not use any remaining doses from this lot. Consult your physician or pharmacist regarding the appropriate course of action and replacement with a properly verified sterile product.
The recalled product
- Product
- Prostaglandin (E1) Injection Solution, 20 mcg/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 — Compounded Injectable
- Hazard
- lack-of-sterility-assurance
- 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#: 11212022@5
- Exp 1/5/2023
Distribution
Distributed nationwide across the United States.
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