Class II · Moderate risk
Ketoprofen USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Control
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.
What was recalled
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Drug: Ketoprofen
- Recalling firm
- The Medicine Shoppe Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1223-2020 · FDA notice
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.
Other Ketoprofen recalls
See all
Class II · Moderate risk
All ketoprofen Products
Lack of Processing Controls
Class II · Moderate risk
Ketoprofen active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Ketoprofen Solution 10% Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Other recalls by The Medicine Shoppe Pharmacy
All 2020 recalls
Class II · Moderate risk
Levothyroxin
Lack of Processing Control
Class II · Moderate risk
Betahistine 16 mg Capsule 180 capsules bottle
Lack of Processing Control
Class II · Moderate risk
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Lack of Processing Control
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
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