The Recall Desk
LowFDA (Drugs)·D-0238-2015·Announced 2014-11-12

Nanophase Recalls Z-COTE HP 1 Zinc Oxide Powder Due to Manufacturing Error

Nanophase Technologies is recalling Z-COTE HP 1 Transparent Zinc Oxide powder because an incorrect amount of raw material was added during manufacturing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a manufacturing deviation in an industrial raw material with no reported injuries or illnesses.

Plain-English summary

Nanophase Technologies Corporation is recalling Z-COTE HP 1 Transparent Zinc Oxide, a powder packaged in 22 kg cartons. The recall involves two specific lots, identified by codes CNNI2901 and CNNI2902, with a total quantity of 1,596 kg.

The recall was initiated due to a Current Good Manufacturing Practice (cGMP) deviation. During the manufacture of these lots, an incorrect amount of a raw material was added. The product is intended for manufacturing, processing, or repacking purposes and was distributed in New Jersey.

Consumers and businesses holding this product should stop using it and contact the recalling firm for instructions on return or disposal. This product is an industrial raw material and is not intended for direct consumer use.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Codes: CNNI2901
  • CNNI2902

Distribution

Distributed in 1 state:

Same manufacturer · Nanophase Technologies Corporation

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