Voluntary Drug Recall -- Ortho-McNeil Pharmaceutical, Inc., Issues A Nationwide Recall Of GRIFULVIN V/Griseofulvin Oral Suspension

Glass bottles of griseofulvin oral suspension (liquid) [GRIFULVIN V®], 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® 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® griseofulvin oral suspension (liquid) may also call 1-800-426-7762. Consumers who believe they are in possession of affected product from Patriot Pharmaceuticals, LLC, 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
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
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® 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