[07 May 2013]
Products Affected - Description
Labetalol injection, 5 mg/mL, Akorn
20 mL vial (NDC 17478-0420-20)
40 mL vials (NDC 17478-0420-40)
Labetalol injection 5 mg/mL, Bedford
20 mL vials (NDC 55390-0130-20)
40 mL vials (NDC 55390-0130-40)
Labetalol injection 5 mg/mL, Hospira
4 mL Carpuject syringe (NDC 00409-2339-34)
Reason for the Shortage
- Bedford has labetalol injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
- Hospira has labetalol on shortage due to manufacturing delays.
- Apotex discontinued their 4 mL vials (NDC 60505-0717-00) in February, 2010. The company could not provide a reason for the discontinuation.
- Sagent had labetalol injection on allocation due to increased demand for the product.
Available Products
Labetalol injection 5 mg/mL, Hospira
20 mL vial (NDC 00409-2267-20)
40 mL vial (NDC 00409-2267-54)
Labetalol injection 5 mg/mL, Sagent
20 mL vials (NDC 25021-0300-20)
40 mL vials (NDC 25021-0300-40)
Estimated Resupply Dates
- Akorn has labetalol 5 mg/mL injection 20 mL and 40 mL vials available as short-dated product.
- Bedford has labetalol injection on long-term back order and the company cannot estimate a release date. These presentations will not be manufactured again until production capacity permits.
- Hospira has labetalol 5 mg/mL 40 mL vials on back order with an estimated release date of April, 2013.
Related Shortages
Updated
May 7, 2013; April 17, 2013; March 27, 2013; March 1, 2013; January 29, 2013; January 2, 2013; December 20, 2012; November 30, 2012; October 31, 2012; October 11, 2012; September 17, 2012; September 5, 2012; July 26, 2012; June 21, 2012; May 2, 2012; April 26, 2012; April 13, 2012; April 4, 2012; February 24, 2012; February 3, 2012; January 27, 2012; December 20, 2011; November 23, 2011; November 3, 2011; October 26, 2011; October 6, 2011; September 14, 2011; August 26, 2011; August 25, 2011; August 4, 2011; June 30, 2011; June 16, 2011; May 23, 2011; May 12, 2011; April 22, 2011; March 30, 2011; March 14, 2011; March 1, 2011; February 2, 2011; January 21, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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