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
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation 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 REPACKING, BASF Corporation, Florham Park, NJ
Drug: Zinc
- Recalling firm
- Nanophase Technologies Corporation
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0238-2015 · 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 2014 recalls
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
Labeling: Illegible label. Writing is rubbing off of labels.
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