Drug 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
D-0238-2015
Product summary
- Event
- Event 69611
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,596 Kg
- Official record key
drug-enforcement:D-0238-2015
Official wording
Reason: cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Code information: Lot Codes: CNNI2901, CNNI2902
Distribution pattern: NJ
Derived failure modes
-
Manufacturing or process control
cGMP Deviation