Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Z-Cote Hp 1 Transparent Zinc Oxide
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Illegible label. Writing is rubbing off of labels.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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. NDC 10117-3004
Affected NDC
10117-3004
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zinc Oxide NDC 10117-3004 |
1 kg/kg | Powder | BASF Corporation | BULK INGREDIENT |
- Recalling firm
- Nanophase Technologies Corporation
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0400-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zinc recalls
See all
Class II · Moderate risk
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Other recalls by Nanophase Technologies Corporation
All 2015 recalls
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
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