Class II · Moderate risk Ongoing
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason Lack of Assurance of Sterility
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
- Recalling firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1221-2022
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.
Other Pentosan recalls
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Class II · Moderate risk Ongoing
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Pentosan Polysulfate Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Ongoing
Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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