Pentec Health Recalls Unsterile Renal Therapies

Due to concerns regarding a lack of sterility, on May 15,2013 Pentec Health voluntarily recalled certain nutritional prescriptions for dialysis. According to the manufacturers, one of the laminar flow hoods utilized in the compounding process may not have been sterile. Since the cleanliness of the hood cannot be guaranteed, Pentec has chosen to withdraw all products which had been compounded in this hood no later than May 2, 2013.

Recall Information

The recalled product was distributed to approximately 163 patients. However, neither the manufacturer nor the FDA has received news of any adverse events related to the recalled renal therapies. If you have experienced serious side effects associated with the recall, contact the U.S. Food and Drug Administration’s MedWatch Program through the following methods:

• fax 1-800-FDA-0178 or 1-800-332-0178
• online by filling out a form here
• mail a form to the address listed online through the FDA

Patients are advised to not take any recalled medications; if the prescription therapy is not sterile, it may increase the risk of infection in patients. For questions call Pentec Health at (800)223-4376, prompt 7, or e-mail Pentec Health at recall@pentechealth.com. If you have any concerns related to recalled renal therapies, contact your healthcare professional for further information.

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