[16 April 2013]
Products Affected - Description
Octreotide injection, Bedford
50 mcg/mL, 1 mL vial (NDC 55390-0160-10)
100 mcg/mL, 1 mL vial (NDC 55390-0161-10)
500 mcg/mL, 1 mL vial (NDC 55390-0162-10)
Octreotide injection, Sandoz
200 mcg/mL, 5 mL vial (NDC 00781-3165-75)
1000 mcg/mL, 5 mL vial (NDC 00781-3164-75)
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)
Reason for the Shortage
- APP reports that the shortage was due to increased demand for the product.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
- Sandoz has octreotide on shortage due to delay of raw materials.
- Mylan Institutional could not provide a reason for the shortage.
- Teva has octreotide on shortage due to manufacturing delays.
- Sandostatin LAR presentations from Novartis are not affected by this shortage.
Available Products
Octreotide injection, 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)
1000 mcg/mL, 5 mL vial (NDC 63323-0379-05)
Octreotide injection, Bedford
200 mcg/mL, 5 mL vial (NDC 55390-0163-01)
1000 mcg/mL, 5 mL vial (NDC 55390-0164-01)
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, 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)
200 mcg/mL, 5 mL vial (NDC 00078-0183-25)
1000 mcg/mL, 5 mL vial (NDC 00078-0184-25)
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)
Estimated Resupply Dates
- Bedford has octreotide 100 mcg/mL 1 mL vials and 500 mcg/mL 1 mL vials on back order and the company cannot estimate a release date. The 50 mcg/mL 1 mL vials are on long term back order and the company will not resume production until capacity permits.
- Teva has all octreotide presentations on long-term back order and the company cannot estimate a release date.
- Sandoz has all octreotide presentations temporarily unavailable and the company cannot estimate a release date.
Related Shortages
Updated
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 2013, 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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