Severity
Low
FDA Drug recall · Reported November 12, 2014
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Nanophase Technologies Corporation recalled Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET… - a low-severity action.
Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET… was recalled by Nanophase Technologies Corporation in November 12, 2014. Reason: cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE…. Check the official notice for the remedy. Verify recall #D-0238-2015 with the FDA Drug before acting.
The recall
Nanophase Technologies Corporation issued this low-severity FDA Drug recall-cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE….
Sourced from official FDA Drug enforcement records. Verify recall #D-0238-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0238-2015) was formally reported on November 12, 2014, with the manufacturer initiating the action on October 20, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Nanophase Technologies Corporation is listed as the recalling firm, operating out of Romeoville, IL. Federal records list the affected scope as 1,596 Kg.
The documented reason for this recall is: cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1. Distribution data in the federal record shows the product reached: NJ. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
1,596 Kg
Related Recalls
6
5 from same agency
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
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0238-2015 |
| Date reported | November 12, 2014 |
| Date initiated | October 20, 2014 |
| Recalling firm | Nanophase Technologies Corporation |
| Firm location | Romeoville, IL |
| Affected scope | 1,596 Kg |
| Distribution | NJ |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 12, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.