ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Out of specification results for micro in hand soap products.
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
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: Out of specification results for micro in hand soap products.
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Reason Microbial contamination
Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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