[22 August 2012]
Products Affected - Description
Amphadase Injection, Amphastar
150 units/mL, 1 mL vials, 10 count (NDC 00548-9090-10)
150 units/mL, 1 mL vials, 25 count (NDC 00548-9090-00)
Reason for the Shortage
- Akorn discontinued their Hydase (bovine hyaluronidase) in April, 2009. The company would not provide a reason for the shortage.
- Amphastar has their Amphadase on back order due to a raw material shortage. The company is awaiting FDA approval for future supply.
- ISTA discontinued their Vitrase 6200 unit single dose vial in early, 2009. This did not affect supply of their Vitrase 200 unit/mL presentation.
- Baxter recalled all lots of Hylenex due to glass particles found in vials during routine inspections in May, 2010.
- Halozyme reassumed all commercial rights of Hylenex from Baxter in late, 2010. The company relaunched the product in December, 2011.
Hylenex Injection, Halozyme
150 units/mL, 1 mL vial, 4 count (NDC 18657-0102-04)
Vitrase Injection (ovine hyaluronidase), ISTA
200 unit/mL, 1.2 mL vials (NDC 67425-0002-10)
Estimated Resupply Dates
- Amphastar has Amphadase (bovine hyaluronidase) on a long-term back order and the company cannot estimate when more product will be available.
- Hylenex and Vitrase are readily available.
August 22, 2012; May 17, 2012; May 9, 2012; February 29, 2012; December 13, 2011; December 7, 2011; September 2, 2011; June 17, 2011; April 14, 2011; February 16, 2011; December 15, 2010; October 13, 2010; June 29, 2010; May 19, 2010; March 17, 2010; January 25, 2010; December 23, 2009; December 11, 2009; November 4, 2009, University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.
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