October 2014 FDA Recall Drug by Nanophase Technologies Corporation
D-0238-2015 - cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

This Class III drug recall was voluntarily initiated by Nanophase Technologies Corporation on October 20, 2014 for the product Drug. The FDA reported the reason for recall as cgmp deviation; the incorrect amount of a raw material was added during the manufacture of two lots of z-cote hp 1.. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0238-2015

Reason for Recall
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Initiated
10-20-2014
Reported
11-12-2014
Quantity
1,596 Kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69611
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.
Nanophase Technologies 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-11-2015
Product Description About Product Description
Full technical description of the product.
Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ

Batch or Lot Expiration Information

Lot# Lot Codes: CNNI2901, CNNI2902