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.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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