Z-COTE HP 1 TRANSPARENT ZINC OXIDE — Class III drug recall D-0238-2015
Terminated recall by Nanophase Technologies Corporation, reported 2014-11-12, distributed in NJ. cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE
| Recall number | D-0238-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nanophase Technologies Corporation, Romeoville, IL, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-06-11 |
| Distributed | NJ |
| Quantity | 1,596 kilograms |
| Reason classes | cgmp |
| Lot numbers | CNNI2901, CNNI2902 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0238-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.