# FDA recall D-0238-2015

> **Nanophase Technologies Corporation** · Class III · drug recall initiated 2014-10-20.

## 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

- **Recall number:** D-0238-2015
- **Recalling firm:** Nanophase Technologies Corporation
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0238-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0238-2015. Source: US FDA. Licensed CC0.

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