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Pentec Health Recall Issued for Compounded Prescription Therapies Due to Sterility Concerns

Pentec Health Recall Issued for Compounded Prescription Therapies Due to Sterility Concerns

pentec healthPentec Health, Inc. has issued a recall of prescriptions for renal patients. No reports regarding adverse effects have been reported that are associated with the prescriptions, but the manufacturer is issuing the recall due to issues concerning the sterility of their products.

About the Drugs Included in the Pentec Health Recall

The drugs included in the recall are in-date nutritional prescriptions that were supplied to renal dialysis centers. Some of the drugs were given directly to the patients. The manufacturer is informing each dialysis center directly, as well as affected in-home patients. The affected drugs were manufactured on or shortly before May 2, 2013.

Reason for the Pentec Recall

The manufacturer has discovered that there was a lack of sterility assurance for these products. The concern was caused by problems with the laminar flow hoods that are utilized during the compounding process. Patients who use recalled products may be at an increased risk of infection. This is due to the possibility of the sterility of the product being compromised.

Recall Parameters

The pharmacy is in the process of recalling unused products that have a beyond-use date that have not yet passed. Consumers of the product who have received prescriptions of this nature should discuss their concerns with their healthcare provider. Healthcare providers who notice any adverse events related to the use of an affected product should also report these events to the Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting a report at the agency’s website. Forms can also be downloaded or mailed to patients upon request.

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