February 2015 FDA Recall Drug by Nanophase Technologies Corporation
D-0400-2015 - Labeling

This Class III drug recall was voluntarily initiated by Nanophase Technologies Corporation on February 12, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0400-2015

Reason for Recall
Labeling: Illegible label. Writing is rubbing off of labels.
Initiated
02-12-2015
Reported
03-11-2015
Quantity
4,104 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70568
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.
01-05-2017
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 repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004

Batch or Lot Expiration Information

Batch# : CNND2902, CNND2903, CNND3001, CNND3002, CNND3003, CNNE0101, CNNE0102, CNNE0103, CNNE0201, CNNE0202, CNNE0203, CNNE0501, CNNE0502, CNNE0503, CNNE0601, CNNE0602, CNNE0603, CNNE0701, CNNE0702, CNNE0703, CNNE0801, CNNE0802, CNNE0803, CNNE0901, CNNE0902, CNNE0903, CNNE1201, CNNE1202, CNNE1203, CNNE1204, CNNE1301, CNNE1302, CNNE1303, CNNE1401, CNNE1402, CNNE1403, CNNE1501, CNNE1502, CNNE1503, CNNE1601, CNNE1602, CNNE1603, CNNE1901, CNNE1902, CNNE1903, CNNE2001, CNNE2801, CNNE2802, CNNE2901, CNNE2902, CNNE3001, CNNE3002, CNNE3003, CNNF0201, CNNF0202, CNNF0203, CNNF0301, CNNF0302, CNNF0303, CNNF0401, CNNF0402, CNNF0403, CNNF0501,CNNF0502, CNNF0601, CNNF0602, CNNF0901, CNNF1903, CNNF2001, CNNF2002, CNNF2003, CNNF2101, CNNF2102, CNNF2301, CNNF2302, CNNF2303, CNNF2401, CNNF2402, CNNF2403, CNNF2501, CNNF2601, CNNF2602, CNNF2603, CNNG0701, CNNG0702, CNNG0703, CNNG0801, CNNG0802, CNNG0901, CNNG0902, CNNG0903, CNNG1001, CNNG1002, CNNG1101, CNNG1102, CNNG1103, CNNG1401, CNNG1402, CNNG1403, CNNG1404, CNNG1501, CNNG1502, CNNG1503, CNNG1602, CNNG1603, CNNG1701, CNNG1702, CNNG1703, CNNG1801, CNNG2801, CNNG2803.