Glass Bottles of Griseofulvin Oral Suspension Recalled

Yael Waknine

Disclosures

April 11, 2007

April 11, 2007 -- Glass bottles of griseofulvin 125-mg/5-mL oral suspension ( Grifulvin V; Ortho Dermatological [Ortho-McNeil Pharmaceutical, Inc]) are being voluntarily recalled from wholesalers and retail pharmacies nationwide, the FDA announced yesterday. Generic versions of the product are also included in the recall and have a Patriot Pharmaceuticals, LLC, label.

The action was based on 2 reports of glass fragments found in bottles of the liquid formulation, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. No cases of injury resulting from accidental ingestion have been reported thus far.

The glass fragments are being attributed to bottle breakage during shipping and handling that was inadvertently concealed by a protective plastic overwrap. Action is being taken to replace the overwrap with one that will allow breakage detection, the company said.

The recall affects lots of 4-oz (120-mL) glass bottles shipped to US distributors between August 23, 2005, and March 14, 2007. Consumers are advised to compare the lot number on the back of the product label to those posted at http://www.aboutgrifulvin.com/recall.asp to determine whether their medication is included in the recall. Those with pharmacy-dispensed bottles should contact their pharmacy to determine whether they are in possession of a recalled item. All affected products should be returned to the pharmacy point of purchase.

Additional information regarding the recall may be obtained by contacting Ortho Dermatological at 1-800-426-7762 or Patriot Pharmaceuticals at 1-800-510-0383; medical questions should be directed to a healthcare provider.

Griseofulvin oral suspension is an antifungal medication indicated for the treatment of tinea capitis, tinea corporis, tinea pedis, tinea unguium (onychomycosis), tinea cruris, and tinea barbae.

Adverse events associated with use of griseofulvin oral suspension should be reported to the appropriate company using the numbers above. Alternatively, the information may be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 

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