Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Coppertone Pure & Simple kids 50 Sunscreen Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
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
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Drug: Zinc
- Recalling firm
- Beiersdorf Inc
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0016-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
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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 Beiersdorf Inc
All 2021 recalls
Class II · Moderate risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple 50 Sunscreen Spray
cGMP Deviations
Class I · High risk
Coppertone SPORT Sunscreen Spray 50
Chemical contamination; presence of benzene
Class I · High risk
Coppertone SPORT MINERAL 50 Sunscreen Spray
Chemical contamination; presence of benzene
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