March 2017 FDA Recall Drug by Fresenius Kabi Usa, Llc
D-0647-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on March 16, 2017 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0647-2017

Reason for Recall
Subpotent Drug
Initiated
03-16-2017
Reported
04-12-2017
Quantity
118,224 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76728
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, 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.
Nationwide within the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2018
Product Description About Product Description
Full technical description of the product.
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

Batch or Lot Expiration Information

Lot# : 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18