D-0238-2015 Class III Terminated
FDA drug recall D-0238-2015 was initiated by Nanophase Technologies Corporation on October 20, 2014 and is designated Class III. 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. The recall status is terminated (terminated June 11, 2015). Affected quantity: 1,596 Kg.
Recall Details
- Product Type
- Drugs
- Report Date
- November 12, 2014
- Initiation Date
- October 20, 2014
- Termination Date
- June 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,596 Kg
Product Description
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 Pattern
NJ
Code Information
Lot Codes: CNNI2901, CNNI2902