Bulletin

Digoxin Oral Products

08 October 2009

Products Affected - Description

Digoxin tablets (Digitek), Mylan Bertek
0.125 mg tablets, 100 count (NDC 62794-0145-01)
0.125 mg tablets, 1000 count (NDC 62794-0145-10)
0.125 mg tablets, 5000 count (NDC 62794-0145-56)
0.25 mg tablets, 100 count (NDC 62794-0146-01)
0.25 mg tablets, 1000 count (NDC 62794-0146-10)
0.25 mg tablets, 5000 count (NDC 62794-0146-56)

Digoxin tablets (Digitek), UDL
0.125 mg tablets, 100 count unit dose (NDC 51079-0945-20)
0.125 mg tablets, 300 count unit dose (NDC 51079-0945-57)
0.25 mg tablets, 100 count unit dose (NDC 51079-0946-20)

Digoxin tablets, Caraco
0.125 mg tablets, 100 count (NDC 57664-0437-88)
0.125 mg tablets, 1000 count (NDC 57664-0437-18)
0.25 mg tablets, 100 count (NDC 57664-0441-88)
0.25 mg tablets, 1000 count (NDC 57664-0441-18)

Lanoxicaps, GlaxoSmithKline
0.1 mg capsules, 100 count (NDC 00173-0272-55) - discontinued
0.2 mg capsules, 100 count (NDC 00173-0274-55) - discontinued

Reason for the Shortage

Actavis Totowa initiated a Class I recall of Digitek tablets due to the possibility that some tablets may contain twice the amount of active ingredient. These digoxin tablets are distributed by Mylan under the Bertek label and by UDL Laboratories.
Lannett's product was on back order due to supply and demand secondary to the Digitek recall.
Westward received approval for their digoxin tablets in late 2007.
Caraco initiated a class I recall of all Caraco brand digoxin products because the tablets may contain too much or too little digoxin.
GlaxoSmithKline states the shortage was due to increased demand for product.
GlaxoSmithKline discontinued Lanoxicaps in March 2008.

Estimated Resupply Dates

Digitek from Mylan Bertek and UDL is unavailable and the companies cannot estimate a return date.
Lannett has all products available including 0.125 mg tablets in the 100 count size (NDC 00527-1324-01), 0.125 mg tablets in the 1000 count size (NDC 00527-1324-10), 0.25 mg tablets in the 100 count size (NDC 00527-1325-01) and 0.25 mg tablets in the 1000 count size (NDC 00527-1325-10).
Westward has all presentations available including the 0.125 mg tablets in the 100 count size (NDC 00143-1240-01), 0.125 mg tablets in the 1000 count size (NDC 00143-1240-10), 0.125 mg tablets in the 5000 count size (NDC 00143-1240-51), 0.25 mg tablets in the 100 count size (NDC 00143-1241-01), 0.25 mg tablets in the 1000 count size (NDC 00143-1241-10), and 0.25 mg tablets in the 5000 count size (NDC 00143-1241-51).
Caraco has recalled all presentations of their digoxin products and cannot estimate when routine supplies will be available.
GlaxoSmithKline has all products available including Lanoxin 0.125 mg tablets in the 100 count size (NDC 00173-0242-55), 0.125 mg tablets in the 1000 count size (NDC 00173-0242-75), 0.25 mg tablets in the 100 count size (NDC 00173-0249-55), 0.25 mg tablets in the 1000 count size (NDC 00173-0249-75), and 0.25 mg tablets in the 5000 count size (NDC 00173-0249-80) available.
Digoxin oral solution is available from Roxane Laboratories. Digoxin oral elixir was discontinued in 2004.

Related Shortages

Bretylium Tosylate Injection— No Longer Available
Disopyramide
Inamrinone Injection
Mexiletine Capsules

Updated

October 8, 2009; August 13, 2009; July 29, 2009; July 1, 2009; June 23, 2009; May 27, 2009; May 4, 2009; April 2, 2009; March 20, 2009; March 19, 2009; February 10, 2009; January 15, 2009; January 8, 2009; December 10, 2008; November 14, 2008; October 3, 2008; August 21, 2008; July 10, 2008; June 2, 2008; May 14, 2008; May 7, 2008; May 2, 2008; April 29, 2008; April 28, 2008, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

Back to Drug Shortage Product Bulletins