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Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Spri...

FDA Recall #D-0394-2016 — Class II — October 19, 2015

Recall #D-0394-2016 Date: October 19, 2015 Classification: Class II Status: Terminated

Product Description

Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Western Drug — Springerville, AZ

Classification

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

Product Type

Drugs

Product Quantity

16 containers

Distribution

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

Code Information

all lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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