Media Advisory: Voluntary Drug Recall - Ortho-McNeil Pharmaceutical, Inc. Issues a Nationwide Recall of Grifulvin V/Griseofulvin Oral Suspension

Affected Product Should Be Returned to Pharmacies

RARITAN, N.J., April 10, 2007 /PRNewswire/ -- Glass bottles of griseofulvin oral suspension (liquid) [GRIFULVIN V(R)], microsize 125 mg/5mL, a prescription medicine used to treat ringworm and other fungal infections, are being voluntarily recalled as a precaution from wholesalers and retail pharmacies nationwide. The voluntary recall is a precaution based on two reports of glass fragments found in bottles of the liquid formulation. Consumers who believe they are in possession of recalled product should contact the pharmacy where the medicine was purchased.

The voluntary recall is being conducted by Ortho Dermatological, Division of Ortho-McNeil Pharmaceutical, Inc., manufacturer of GRIFULVIN V(R) and griseofulvin oral suspension, which has a Patriot Pharmaceuticals, L.L.C., label. This voluntary recall is limited to the liquid formulation of the medication and does not include any other dosage form.

The two reports of glass fragments are believed to be the result of bottle breakage during shipping and handling. A plastic over-wrap placed on bottles of this medicine for protection might have made it difficult to detect breakage that occurred during shipping and handling, and action is being taken to change the over-wrap to prevent this possible occurrence in the future. In the unlikely event that a damaged bottle has been dispensed, a potential exists for injury due to accidental ingestion of glass fragments. There have been no reports of adverse events from the reported glass fragments in broken bottles.

The lots were shipped to distributors in the United States only between August 23, 2005 and March 14, 2007. Lot numbers are listed at the end of this press advisory and posted on www.aboutgrifulvin.com. Lot numbers can be found on the back of the product label only on four-ounce (120 mL) glass bottles filled by the manufacturer. Consumers with pharmacy-dispensed bottles, which were filled at the pharmacy and do not contain lot numbers, should contact the pharmacy where they purchased the medicine to determine if they are in possession of product that has been recalled.

In addition to contacting the pharmacy where the medicine was purchased, consumers who believe they are in possession of recalled bottles of GRIFULVIN V(R) griseofulvin oral suspension (liquid) may also call 1-800-426-7762. Consumers who believe they are in possession of affected product from Patriot Pharmaceuticals, L.L.C., griseofulvin oral suspension (liquid), may call 1- 800-510-0383. Consumers should direct medical questions to their health care providers. Adverse reactions experienced with the use of this product should be reported to the company using the telephone numbers above.

The company is voluntarily conducting this recall in cooperation with the U.S. Food and Drug Administration and sending urgent recall letters to wholesalers and pharmacies nationwide. In addition, the company is taking action to supply new inventory to its customers.



             Griseofulvin Oral Suspension (microsize) 125 mg/5ml

                      (PATRIOT Pharmaceuticals, L.L.C.)


    Lot No.  Expiry Date     Lot No.  Expiry Date    Lot No. Expiry Date

    5LA410   03/31/2007      6BA565   03/31/2008     6KA031   10/31/2008

    5LA411   03/31/2007      6BA566   03/31/2008     6KA032   10/31/2008

    5LA412   03/31/2007      6CA593   03/31/2008     6KA033   10/31/2008

    5LA413   03/31/2007      6CA594   03/31/2008     6KA034   10/31/2008

    5LA414   03/31/2007      6CA595   04/30/2008     6KA035   10/31/2008

    5LA415   03/31/2007      6CA596   04/30/2008     6KA036   10/31/2008

    5LA416   03/31/2007      6CA597   04/30/2008     6KA990   09/30/2008

    5LA417   03/31/2007      6DA622   04/30/2008     6KA991   09/30/2008

    5LA418   03/31/2007      6DA623   05/31/2008     6LA109   10/31/2008

    5NA469   03/31/2007      6DA624   05/31/2008     6LA110   10/31/2008

    5NA470   03/31/2007      6DA625   05/31/2008     6LA111   10/31/2008

    5NA471   03/31/2007      6DA626   06/30/2008     6LA112   11/30/2008

    6AA494   01/31/2008      6GA725   07/31/2008     6LA113   11/30/2008

    6AA495   01/31/2008      6GA726   07/31/2008     6LA114   11/30/2008

    6AA496   01/31/2008      6GA727   07/31/2008     6LA128   11/30/2008

    6AA497   01/31/2008      6GA728   07/31/2008     6LA130   11/30/2008

    6AA505   01/31/2008      6GA729   07/31/2008     6MA173   11/30/2008

    6AA506   01/31/2008      6HA839   07/31/2008     6MA174   11/30/2008

    6AA507   01/31/2008      6HA840   07/31/2008     6MA175   11/30/2008

    6AA508   01/31/2008      6HA841   08/31/2008     6MA176   11/30/2008

    6AA509   01/31/2008      6HA842   08/31/2008     6MA194   11/30/2008

    6AA516   01/31/2008      6HA843   08/31/2008     6MA231   11/30/2008

    6AA517   01/31/2008      6HA844   08/31/2008     6MA232   11/30/2008

    6AA518   02/29/2008      6HA845   08/31/2008     6MA233   12/31/2008

    6AA519   02/29/2008      6HA847   08/31/2008     6MA234   12/31/2008

    6AA520   02/29/2008      6HA848   08/31/2008     6MA235   12/31/2008

    6AA521   02/29/2008      6HA849   08/31/2008     6MA236   12/31/2008

    6AA532   02/29/2008      6HA850   08/31/2008     6MA238   12/31/2008

    6AA533   02/29/2008      6HA867   09/30/2008     6MA239   12/31/2008

    6AA534   02/29/2008      6HA870   09/30/2008     6MA240   12/31/2008

    6AA535   02/29/2008      6HA871   09/30/2008     6MA241   12/31/2008

    6AA536   02/29/2008      6HA872   09/30/2008     6MA242   01/31/2009

    6BA561   03/31/2008      6HA875   09/30/2008     6MA246   01/31/2009

    6BA562   03/31/2008      6KA028   09/30/2008     6MA247   01/31/2009

    6BA563   02/29/2008      6KA029   10/31/2008

    6BA564   03/31/2008      6KA030   10/31/2008




    GRIFULVIN V(R) brand (griseofulvin oral suspension) microsize

                               Suspension 125mg/5ml

    Lot No.  Expiry Date

    5CA136   03/31/2007

    5CA138   03/31/2007

    5CA139   03/31/2007

    5CA143   03/31/2007

    5CA144   03/31/2007

    5CA145   03/31/2007

    5CA146   03/31/2007

    5CA147   03/31/2007

    5CA148   03/31/2007

    5CA149   03/31/2007

    5CA150   03/31/2007

    5CA151   03/31/2007

    5CA164   03/31/2007

    5CA165   04/30/2007

    6CA616   03/31/2008

    6DA636   04/30/2008

    6DA637   04/30/2008

    6DA638   04/30/2008

    6DA640   04/30/2008

    6DA646   04/30/2008

    6DA647   04/30/2008

    6DA648   04/30/2008

    6DA649   04/30/2008

    6DA657   04/30/2008

    6EA670   05/31/2008

    6GA731   07/31/2008

    6HA846   07/31/2008

    6HA851   08/31/2008

    6HA868   07/31/2008

    6HA873   09/30/2008

    6HA874   08/31/2008

    6JA936   09/30/2008

    6JA937   09/30/2008

    6KA987   09/30/2008

    6KA988   09/30/2008

    6KA989   09/30/2008

    6MA193   11/30/2008

CONTACT: Greg Panico, Office, +1-908-927-3715, Mobile, +1-908-240-2011

Web site: http://www.aboutgrifulvin.com//

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Posted: April 2007


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