Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
suntegrity (Zinc Oxide)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Affected NDC
69949-0152-01
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 |
|---|---|---|---|---|
| Impeccable Skin - Buff Zinc Oxide NDC 69949-0152 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
- Recalling firm
- Synchronicity Spa INC, Dba Sunte
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0588-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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Class II · Moderate risk
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Class II · Moderate risk
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Other recalls by Synchronicity Spa INC, Dba Sunte
All 2024 recalls
Class II · Moderate risk
suntegrity
CGMP Deviations
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