Pedinol Pharmacal Inc. Announces Health Advisory for Gris-PEG (griseofulvin ultramicrosize) 125mg and 250mg

Date of Recall

2012-02-03

Recall Details

- February 2, 2012 - Pedinol Pharmacal Inc. today announced that it is advising healthcare professionals, pharmacists and patients of a potential problem with Gris-PEG® (griseofulvin ultramicrosize) 125mg and 250mg manufactured and packaged by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product. After a thorough analysis, Pedinol estimates the likelihood of this occurring in medication dispensed to patients is low.

Pedinol reports that they are not aware of any product mix-ups with respect to these products since 2009. Pedinol is not aware of any patient having experienced a confirmed product mix-up nor any adverse events attributable to product mix-up. Nonetheless, to ensure continued patient safety and access to these needed medicines, Pedinol advises healthcare professionals, pharmacists and patients to examine Gris-PEG® tablets in their possession and ensure that all tablets are the same. Pedinol is providing instructions on how to identify an incorrect tablet in these medicines.

"We are committed to ensuring that all healthcare professionals, pharmacists and patients are aware of this very low risk," said Gary Strauss, CEO of Pedinol. "We are also committed to ensuring the highest standard for patients who rely on our product."

The likelihood of finding a wrong tablet in Gris-PEG® dispensed to patients is low and patients should not be unduly alarmed. For medications already in homes and pharmacies, there are simple steps provided at www.pedinol.com and www.grispeg.com to identify affected products.

For any questions, patients should contact Pedinol Pharmacal Inc. at 1-800-733-4665 or ask their pharmacist or doctor for additional help in identifying whether there are any problems with their medication.

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