Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

FDA Recall #D-0185-2023 — Class II — December 22, 2022

Recall #D-0185-2023 Date: December 22, 2022 Classification: Class II Status: Terminated

Product Description

Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for Recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Recalling Firm

Pharmacy Innovations — Erie, PA

Classification

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

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide in the USA

Code Information

20221012@21 t20221025@32 t20221109@7

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated