Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Zinc Oxide Paste 25%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
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
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
Affected NDC
51522-0694-05
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
- Recalling firm
- Fagron, Inc
- NDC code
- 51522-0694-5
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0695-2017 · 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 Fagron, Inc
All 2017 recalls
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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