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

2007-04-10 14:26:12 -

RARITAN, N.J., April 10 /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 http://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

Source: Ortho-McNeil Pharmaceutical, Inc.