Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded ...

FDA Recall #D-0111-2023 — Class II — December 30, 2022

Recall #D-0111-2023 Date: December 30, 2022 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Northern VA Compounders PLLC — Sterling, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

108 vials

Distribution

Nationwide in the USA

Code Information

Lot#: 11252022@12, Exp 1/9/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated