The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0111-2023·Announced 2023-01-18

FDA Recalls Prostaglandin E1 Injection for Lack of Sterility Assurance

Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution due to lack of sterility assurance. The recall affects 108 vials distributed nationwide.

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 with no reported illnesses or hospitalizations. The hazard—lack of sterility assurance—is significant for injectable medications but remains theoretical. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution, 25 mcg/mL in 2.5 mL multiple-dose vials. The affected lot number is 11252022@12, with an expiration date of 1/9/2023. The product was compounded by Akina Pharmacy in Sterling, Virginia. A total of 108 vials are subject to recall.

The recall was issued due to the manufacturer's inability to assure that the product met required sterility standards.

The affected product was distributed nationwide in the United States. Patients who may have received injections from affected vials should contact their healthcare provider. Remaining vials from this lot should not be used.

The recalled product

Product
Prostaglandin (E1) Injection Solution, 25mcg/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
Affected units
108

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#: 11252022@12
  • Exp 1/9/2023

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.

See all 25 products in this recall →

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