Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Lack of Assurance of Sterility
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