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Octreotide Injection

[22 July 2014]

Products Affected - Description

Octreotide injection, Bedford
50 mcg/mL, 1 mL vial (NDC 55390-0160-10) - discontinued
100 mcg/mL, 1 mL vial (NDC 55390-0161-10) - discontinued
200 mcg/mL, 5 mL vial (NDC 55390-0163-01) - discontinued
500 mcg/mL, 1 mL vial (NDC 55390-0162-10) - discontinued
1000 mcg/mL, 5 mL vial (NDC 55390-0164-01) - discontinued

Octreotide injection, Fresenius Kabi (formerly APP)
1000 mcg/mL, 5 mL vial (NDC 63323-0379-05)

 
Octreotide injection, Sagent
50 mcg/mL, 1 mL vial (NDC 25021-0451-01)
100 mcg/mL, 1 mL vial (NDC 25021-0452-01)
200 mcg/mL, 5 mL vial (NDC 25021-0454-05)
500 mcg/mL, 1 mL vial (NDC 25021-0453-01)
1000 mcg/mL, 5 mL vial (NDC 25021-0455-05)
 
Octreotide injection, Teva
50 mcg/mL, 1 mL vial (NDC 00703-3301-04)
100 mcg/mL, 1 mL vial (NDC 00703-3311-04)
500 mcg/mL, 1 mL vial (NDC 00703-3321-04)
200 mcg/mL, 5 mL vial (NDC 00703-3333-01)
1000 mcg/mL, 5 mL vial (NDC 00703-3343-01)
 
Octreotide injection, West-Ward
1000 mcg/mL, 5 mL vial (NDC 55390-0164-01)

 
Octreotide injection, Wockhardt
100 mcg/mL, 1 mL vial (NDC 64679-0633-02)
500 mcg/mL, 1 mL vial (NDC 64679-0635-02)
200 mcg/mL, 5 mL vial (NDC 64679-0634-01)
1000 mcg/mL, 5 mL vial (NDC 64679-0632-01)
 
Sandostatin, Novartis
200 mcg/mL, 5 mL vial (NDC 00078-0183-25)
1000 mcg/mL, 5 mL vial (NDC 00078-0184-25)

Reason for the Shortage

  • Fresenius Kabi (formerly APP) reports that the shortage is due to increased demand for the product.
  • Sandoz discontinued octreotide injection in 2nd quarter 2013.
  • Sagent has octreotide on shortage due to increased demand for the product.
  • Teva has octreotide on shortage due to manufacturing delays.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired octreotide injection from Bedford in July 2014. West-Ward will actively market octreotide injection.
  • Wockhardt has octreotide on back order due to an import ban.
  • Sandostatin LAR presentations from Novartis are not affected by this shortage

Available Products

Octreotide injection, Caraco
50 mcg/mL, 1 mL ampule (NDC 62756-0348-44)
100 mcg/mL, 1 mL ampule (NDC 62756-0349-44)
500 mcg/mL, 1 mL ampule (NDC 62756-0351-44)
200 mcg/mL, 5 mL vial (NDC 62756-0350-40)
1000 mcg/mL, 5 mL vial (NDC 62756-0352-40)
 
Octreotide injection, Fresenius Kabi (formerly APP)
50 mcg/mL, 1 mL vial (NDC 63323-0365-01)
100 mcg/mL, 1 mL vial (NDC 63323-0376-01)
200 mcg/mL, 5 mL vial (NDC 63323-0378-05)
500 mcg/mL, 1 mL vial (NDC 63323-0377-01)

Octreotide injection, Mylan Institutional
50 mcg/mL, 1 mL syringe (NDC 67457-0239-01)
100 mcg/mL, 1 mL syringe (NDC 67457-0245-01)
500 mcg/mL, 1 mL syringe (NDC 67457-0246-01)

Sandostatin, Novartis
50 mcg/mL, 1 mL ampule (NDC 00078-0180-01)
100 mcg/mL, 1 mL ampule (NDC 00078-0181-01)
500 mcg/mL, 1 mL ampule (NDC 00078-0182-01)

Estimated Resupply Dates

  • Fresenius Kabi has octreotide 1000 mcg/mL 5 mL vials on back order and the company estimates a release date in mid-August 2014.
  • Sagent has octreotide 50 mcg/mL 1 mL vials, 100 mcg/mL 1 mL vials and 1000 mcg/mL 5 mL vials on back order and the company estimates a release date in July 2014. Octreotide 500 mcg/mL 1 mL vials are on back order and the company estimates a release date in August 2014. Octreotide 200 mcg/mL 5 mL vials are on back order and the company estimates a release date in October 2014.
  • Teva has all octreotide presentations on long-term back order and the company cannot estimate a release date.
  • West-Ward estimates octreotide injection will be available for ordering and shipping starting in late-July 2014.
  • Wockhardt has all octreotide presentations on back order and the company cannot estimate a release dates for these products.
  • Novartis has Sandostatin 200 mcg/mL 5 mL vials available but the product has short expiration dating (April 2015). Novartis has Sandostatin 1000 mcg/mL 5 mL vials available but the product has short expiration dating (May 2015).

Related Shortages

Updated

July 22, 2014; June 19, 2014; June 12, 2014; June 2, 2014; May 30, 2014; May 22, 2014; May 8, 2014; May 7, 2014; April 25, 2014; April 10, 2014; March 27, 2014; March 6, 2014; March 3, 2014; February 14, 2014; February 10, 2014; January 31, 2014; November 1, 2013; October 25, 2013; August 28, 2013; July 11, 2013; May 24, 2013; April 16, 2013; April 11, 2013; February 27, 2013; December 17, 2012; October 11, 2012; August 22, 2012; July 19, 2012; June 1, 2012; April 5, 2012; March 23, 2012; February 27, 2012; February 14, 2012; January 4, 2012; December 16, 2011; November 23, 2011; November 9, 2011; November 3, 2011; October 18, 2011; September 20, 2011; September 14, 2011; September 6, 2011; August 17, 2011; July 21, 2011; June 6, 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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