Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Processing Controls
All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
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 Lack of Processing Control
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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