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Class III: unlikely to cause harmTerminated

Nanophase Technologies Z-Cote Hp 1 Transparent Zinc Oxide Recall

Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, N…

Nanophase Technologies Corporation · Romeoville, IL

Risk level
Class III
Reported by FDA
Nov 12, 2014
Recall ID
D-0238-2015
Check your lot numberHow we source this data

Summary

Nanophase Technologies recalled Z-Cote Hp 1 Transparent Zinc Oxide starting Oct 20, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0238-2015 on Nov 12, 2014. Reason: cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1. Status: Terminated.

Why it was recalled

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Product description

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

Lot numbers, UPCs & expiration codes

Lot Codes: CNNI2901, CNNI2902

Where it was sold

NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0238-2015
Classification
Class III
Status
Terminated
Recall initiated
Oct 20, 2014
FDA report date
Nov 12, 2014
Quantity
1,596 Kg
Recall type
Voluntary: Firm initiated
Recalling firm
Nanophase Technologies Corporation

Original FDA data

Every field from FDA enforcement report D-0238-2015, exactly as published.

Show all FDA fields
City
Romeoville
State
IL
Status
Terminated
Country
United States
Event ID
69611
Address
1319 Marquette Dr
Code information
Lot Codes: CNNI2901, CNNI2902
Postal code
60446-4055
Report date
Nov 12, 2014
Product type
Drugs
Recall number
D-0238-2015
Classification
Class III
Recalling firm
Nanophase Technologies Corporation
Product quantity
1,596 Kg
Termination date
Jun 11, 2015
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
NJ
Recall initiation date
Oct 20, 2014
Initial firm notification
E-Mail
Center classification date
Nov 6, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0238-2015, published Nov 12, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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