August 2017 FDA Recall Drug by Shata Trading, Inc.
D-0084-2018 - Marketed Without an Approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Shata Trading, Inc. on August 22, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in NY and the recall is currently terminated.

Recall Number: D-0084-2018

Reason for Recall
Marketed Without an Approved NDA/ANDA
Initiated
08-22-2017
Reported
11-29-2017
Quantity
96 foil packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78257
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.
Shata Trading, Inc.
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-09-2020
Product Description About Product Description
Full technical description of the product.
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239

Batch or Lot Expiration Information

Lot# 16L63
Lot# 223190