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; deficiencies observed during FDA inspection
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.
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
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; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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