July 2017 FDA Recall Drug by Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
D-1040-2017 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical on July 12, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in There were only one customer in California and the recall is currently terminated.
Recall Number: D-1040-2017
CGMP Deviations
07-12-2017
08-09-2017
120 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
There were only one customer in California
01-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Batch or Lot Expiration Information
Lot# 03022017+44906; BUD 08/29/17
