Our contract manufacturer (Novartis Consumer Healthcare) has notified us that several of their own Over-the-Counter "OTC" products have been cited by the FDA for including "stray" or different product tablets packaged together improperly. After a thorough investigation and analysis, we have determined that to the best of our knowledge NO PEDINOL PRODUCTS WERE EFFECTED. In an over-abundance of caution, Pedinol is informing you of this matter. In essence, Pedinol has received no product complaints of stray tablets in its Gris-PEG® (griseofulvin ultramicrosize) 125mg or 250mg tablets. Because Pedinol's Gris-PEG® product is pharmacist dispensed by prescription only, the chances of a product mix-up are even further reduced. The tablets involved appear to have been limited to OTC products for consumers only.
Pedinol's principal concern is the health and well-being of its patients. In order to minimize the impact of this manufacturing issue on you we recommend you click on the appropriate link below.
- Click here to read the letter to healthcare professionals
- Click here to read the letter to pharmacists
The following visual guide (PDF) is provided to verify the appearance of Gris-PEG® 125 mg and 250 mg tablets.
Gris-PEG® (ultramicrosize griseofulvin tablets, USP) 125 mg & 250 mg
|
Strength
|
NDC
|
Tablet Image
|
Color
|
Shape
|
Tablet Imprint
|
|
Gris-PEG
125 mg*
|
0884-0763-04
|
|
White
|
Elliptical
|
Scored, embossed “Gris-PEG” on one side and “125” on the other
|
|
Gris-PEG
250 mg*
|
0884-0773-04
|
|
White
|
Capsule
|
Scored, embossed “Gris-PEG” on one side and “250” on the other
|
*Note: Tablets not shown at actual size
Gris-PEG® (griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed “Gris-PEG” on one side and “125” on the other. Gris-PEG (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed “Gris-PEG” on one side and “250” on the other. The 125 mg strength is available in bottles of 100 (NDC 0884-0763-04). The 250 mg strength is available in bottles of 100 (NDC 0884-0773-04). Both strengths are film-coated.
Pedinol’s principal concern is the health and well-being of its patients. Please contact Pedinol at 1-800-733-4665 should you have any questions or need to report a complaint.
Manufactured for:
PEDINOL PHARMACAL INC.
30 Banfi Plaza North
Farmingdale, NY 11735 |
