FDA-Drug2014-11-12Class III

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

Nanophase Technologies Corporation
Hazard

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Sold states
NJ
Affected count
1,596 Kg
Manufactured in
1319 Marquette Dr, N/A, Romeoville, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2015

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