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Clarithromycin Immediate-Release Tablets

[17 September 2014]

Products Affected - Description

Clarithromycin immediate-release tablets, Ranbaxy
250 mg, 60 count (NDC 63304-0725-60)
250 mg, 100 count (NDC 63304-0725-01)
500 mg, 60 count (NDC 63304-0726-60)
500 mg, 100 count (NDC 63304-0726-01)
 
Biaxin immediate-release tablets, Abbvie
250 mg, 100 count unit dose (NDC 00074-3368-11) - discontinued
500 mg, 100 count, unit dose (NDC 00074-2586-11) - discontinued
 
Clarithromycin immediate-release tablets, Mylan
250 mg, 60 count (NDC 00378-8250-91) - discontinued
500 mg, 60 count (NDC 00378-8500-91)- discontinued
 
Clarithromycin immediate-release tablets, Teva
250 mg, 60 count (NDC 00093-7157-06)
500 mg, 60 count (NDC 00093-7158-06)

 
Clarithromycin immediate-release tablets, UDL
500 mg, 100 count, unit dose (NDC 51079-0673-06) - discontinued
 
Clarithromycin immediate-release tablets, Wockhardt
250 mg, 60 count (NDC 64679-0954-01)
500 mg, 60 count (NDC 64679-0949-01)

Reason for the Shortage

  • Ranbaxy has an import ban on their products.
  • Apotex import ban has been lifted, but the company is not marketing clarithromycin immediate-release tablets in the US.
  • Abbvie discontinued Biaxin 500 mg 100 count unit-dose in 2014.
  • Mylan discontinued clarithromycin tablets in 2013.
  • Teva could not provide a reason for the shortage. 
  • UDL discontinued clarithromycin 500 mg 100 count unit-dose in May 2013.
  • Wockhardt has clarithromycin tablets on shortage due to regulatory delays.

Available Products

Biaxin immediate-release tablets, Abbvie
250 mg, 60 count (NDC 00074-3368-60)
500 mg, 60 count (NDC 00074-2586-60)

Clarithromycin immediate-release tablets, Sandoz
250 mg, 60 count (NDC 00781-1961-60)
500 mg, 60 count (NDC 00781-1962-60)

Estimated Resupply Dates

  • Ranbaxy has clarithromycin immediate-release products on back order and the company cannot estimate a release date.
  • Teva has clarithromycin 250 mg and 500 mg immediate-release tablets on back order and the company estimates a release date in late-October 2014.
  • Wockhardt has clarithromycin immediate-release tablets on back order and the company cannot provide a release date.

Related Shortages

Updated

September 17, 2014; July 9, 2014; May 1, 2014; March 5, 2014; January 8, 2014; December 6, 2013; September 13, 2013; June 6, 2013; March 8, 2013; January 4, 2013; October 22, 2012; August 2, 2012; May 25, 2012; March 14, 2012; January 27, 2012; December 28, 2011; December 16, 2011; November 18, 2011; October 19, 2011; August 12, 2011; July 29, 2011; July 8, 2011; June 16, 2011; May 13, 2011; May 11, 2011; April 8, 2011; March 11, 2011; February 9, 2011; January 28, 2011; January 25, 2011, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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