Drug & medication recalls Moderate risk

Prostaglandin Injection Solution recalled over sterility concerns

Recall date
December 30, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Northern VA Compounders PLLC recalls Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23…
Recall number
D-0112-2023
FDA classification
Class II
Brand / firm
Northern VA Compounders PLLC
Sold / distributed
Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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