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Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up

Fri, 02/03/2012 - 12:31pm
U.S. Food & Drug Administration

AUDIENCE: Consumer

ISSUE: Pedinol Pharmacal Inc. notified 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.

BACKGROUND: Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of ringworm infections.

RECOMMENDATION:  Healthcare professionals, pharmacists and patients are advised to examine Gris-PEG tablets in their possession and ensure that all tablets are the same. For medications already in homes and pharmacies, there are simple steps provided at www.pedinol.com disclaimer icon and www.grispeg.com disclaimer icon to identify affected products.

[02/03/2012 - Press Release - Pedinol Pharmacal Inc.]

Related Medwatch Alert:

[01/09/2012] Novartis Consumer Health Over-The-Counter Products Recall

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