May 2017 FDA Recall Drug by X-gen Pharmaceuticals Inc.
D-1059-2017 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by X-gen Pharmaceuticals Inc. on May 17, 2017 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1059-2017

Reason for Recall
Presence of Foreign Substance: potential presence of plastic particles.
Initiated
05-17-2017
Reported
08-16-2017
Quantity
9,816 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77834
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.
X-Gen Pharmaceuticals 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.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-05-2018
Product Description About Product Description
Full technical description of the product.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

Batch or Lot Expiration Information

Lot# : 23701.158A, EXP 10/31/18