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Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC ...

FDA Recall #D-0609-2020 — Class II — November 12, 2019

Recall #D-0609-2020 Date: November 12, 2019 Classification: Class II Status: Terminated

Product Description

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

Reason for Recall

Discoloration; Hazy solution found in one vial instead of a clear solution.

Recalling Firm

AuroMedics Pharma LLC — East Windsor, NJ

Classification

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

Product Type

Drugs

Product Quantity

59,500 vials

Distribution

Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.

Code Information

Lot CFD190004, exp. date August 2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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