Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
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.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Lack of Assurance of Sterility
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
cGMP deviations
cGMP deviations
cGMP deviations
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