Nanophase Technologies Recalls Z-COTE HP 1 Transparent Zinc Oxide Powder
Nanophase Technologies is recalling 4,104 cartons of Z-COTE HP 1 Transparent Zinc Oxide powder due to illegible labels where writing is rubbing off.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 hazard is limited to illegible labels, which falls under the 'packaging-only problems' or 'documentation issues' criteria for a Low severity score.
Plain-English summary
Nanophase Technologies Corporation is recalling 4,104 cartons of Z-COTE HP 1 Transparent Zinc Oxide, Zinc Oxide (and) Triethoxycaprylylsilane, powder. The product is packaged in double plastic liners in a single fiber carton and is intended for manufacturing, processing, or repackaging. The recall was initiated because the labels on the product are illegible, with writing rubbing off the labels.
The affected product is identified by NDC 10117-3004 and includes specific batch numbers listed in the recall documentation. The distribution pattern for this recall is limited to New Jersey (NJ). The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and businesses who have purchased this product should stop using it and contact Nanophase Technologies Corporation for further instructions on how to return or dispose of the product. The recall is primarily a labeling issue affecting the legibility of the product identification.
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 repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446.…
- Manufacturer
- Nanophase Technologies Corporation
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
- Affected units
- 4,104
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 (20)
- Batch #: CNND2902
- CNND2903
- CNND3001
- CNND3002
- CNND3003
- CNNE0101
- CNNE0102
- CNNE0103
- CNNE0201
- CNNE0202
- CNNE0203
- CNNE0501
- CNNE0502
- CNNE0503
- CNNE0601
- CNNE0602
- CNNE0603
- CNNE0701
- CNNE0702
- CNNE0703
Distribution
Distributed in 1 state:
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