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FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Barry D. Graham
607-436-9088
FOR IMMEDIATE RELEASE -- Oneonta, NY -- January 30, 2004 -- Graham Development Inc., Oneonta, NY is initiating a voluntary recall of one lot of Vantin 200 mg tablets (Lot #K08210301), a prescription antibiotic. There is a possibility product dispensed from this lot may contain a different drug known as Lanoxin (digoxin), a heart medication. Consumers who inadvertently take Lanoxin assuming it is Vantin are at risk of serious health consequences such as ventricular arrhythmia and death. Affected drug distributors and pharmacies are being notified.
Consumers who have Vantin tablets should check their prescription bottles. The bottles may identify Graham Development Inc. or Pharmacia & Upjohn Company as the source of the product. Consumers who have this product with a prescription dispensed after December 12, 2003, should immediately check with their pharmacists. Since Vantin tablets and Lanoxin tablets are different in color, size, shape and markings, pharmacists will be able to identify the medication. Vantin tablets are football shaped, orange/red, film coated and embossed with "U" and "3618" and Lanoxin tablets are round, white tablets, scored and embossed "LANOXIN" and "X3A."
To date there are no reported injuries, and the company is actively working with FDA and affected pharmacies in this voluntary recall.
There are approximately 420 bottles in distribution. These were shipped to pharmacies and distributors in the northeastern United States, Kentucky, Minnesota, Missouri and South Dakota, beginning on December 12, 2003. The product as distributed to pharmacists is labeled Vantin with NDC #0009-3618-01, Lot K08210301, Exp. 04/2008. Product dispensed to consumers may not include the NDC # or lot number.
This voluntary recall is being initiated based on a single incident in which a pharmacist discovered Lanoxin tablets inside a bottle labeled as Vantin. Preliminary findings indicate this problem is limited to only a one bottle from this lot.
If you have questions about this recall, you may contact Barry Graham at Graham Development, Inc., 607-436-9088.
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