FDA recall D-0238-2015

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

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.

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2014-10-20

Report date

2014-11-12

Termination date

2015-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Romeoville, IL, United States

Primary source

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