November 2019 FDA Recall Drug by Auromedics Pharma Llc
D-0609-2020 - Discoloration; Hazy solution found in one vial instead of a clear solution.

This Class II drug recall was voluntarily initiated by Auromedics Pharma Llc on November 12, 2019 for the product Drug. The FDA reported the reason for recall as discoloration; hazy solution found in one vial instead of a clear solution.. The product was distributed in Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0609-2020

Reason for Recall
Discoloration; Hazy solution found in one vial instead of a clear solution.
Initiated
11-12-2019
Reported
12-11-2019
Quantity
59,500 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84244
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-21-2021
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot CFD190004, exp. date August 2020