January 2015 FDA Recall Drug by Anazaohealth Corporation
D0384-2015 - Good Manufacturing Practices Deviations

This Class II drug recall was voluntarily initiated by Anazaohealth Corporation on January 26, 2015 for the product Drug. The FDA reported the reason for recall as good manufacturing practices deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D0384-2015

Reason for Recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Initiated
01-26-2015
Reported
02-18-2015
Quantity
51 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70465
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.
AnazaoHealth Corporation
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2015
Product Description About Product Description
Full technical description of the product.
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.

Batch or Lot Expiration Information

Lot# : 112614-1MC-82186 Exp 5/26/2015; 112614-1MC-82187 Exp 5/26/2015; 112614-1MC-82188 Exp 05/26/205 ;112614-1MC-82189 Exp 5/26/2015