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Colchicine Tablets

Last Updated: November 12, 2010
Status: Resolved

Products Affected - Description

Colchicine tablets, Excellium
0.6 mg, 100 count (NDC 64125-0104-01)
0.6 mg, 1000 count (NDC 64125-0104-10)

Colchicine tablets, Vision Pharma
0.6 mg, 100 count (NDC 68013-0001-01)
0.6 mg, 500 count (NDC 68013-0001-05)
0.6 mg, 1000 count (NDC 68013-0001-10)
 
Colchicine tablets, Westward
0.6 mg, 100 count (NDC 00143-1201-01)
0.6 mg, 1000 count (NDC 00143-1201-10)
0.6 mg, unit dose 100 count (NDC 00143-1201-25)

Reason for the Shortage

  • FDA ordered manufacturers to stop production, distribution, and marketing of unapproved single-ingredient oral colchicine on September 30, 2010. Manufacturers have 45 days to stop production and 90 days to stop shipping unapproved products. 
  • Vision Pharma and Excellium no longer have colchicine products available. The companies could not provide any additional information about the products.
  • Westward has discontinued all colchicine presentations due to FDA requirements.
  • Colcrys is currently the only colchicine tablet that is FDA-approved.

Estimated Resupply Dates


FDA Approved Products
  • AR Pharmaceuticals have Colcrys available in 30 count (NDC 13310-0119-07) and 100 count (NDC 13310-0119-01) sizes. All other presentations have been discontinued.

 
Non-FDA Approved Products
  • Westward hasdiscontinued all colchicine presentations.
  • Vision Pharma does not have colchicine tablets available. Vision Pharma would not provide any other information about this product.
  • Excellium does not have colchicine tablets available.

Related Shortages

Updated

November 12, 2010; August 18, 2010; June 23, 2010; April 27, 2010; March 24, 2010; February 19, 2010; January 5, 2010, University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.

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