[10 May 2013]
Products Affected - Description
Sodium Chloride 23.4% Solution for Injection
Sodium Chloride 23.4%, APP
100 mL vials (NDC 63323-0088-61)
200 mL vials (NDC 63323-0088-63)
Sodium Chloride 23.4%, Hospira
100 mL bulk glass container (NDC 00074-1141-02)
250 mL bulk glass container (NDC 00074-1130-02)
Sodium Chloride 23.4%, American Regent
30 mL vials (NDC 00517-2930-25)
100 mL vials (NDC 00517-2900-25)
Sodium Chloride 14.6% Solution for Injection
Sodium Chloride 14.6%, APP
20 mL vials (NDC 63323-0139-20) - discontinued
Sodium Chloride 14.6%, Hospira
20 mL vials (NDC 00409-6657-73)
40 mL vials (NDC 00409-6660-75)
Reason for the Shortage
- American Regent recalled several lots of concentrated sodium chloride 23.4% 30 mL and 100 mL vials on March 15, 2011.
- American Regent had temporarily suspended distribution of the majority of their drug products including sodium chloride 23.4% injections in April, 2011.
- American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
- Baxter discontinued their sodium chloride 250 mL presentation in 2008.
- APP has sodium chloride concentrated solution on shortage due to increased demand. APP discontinued sodium chloride 14.6% 20 mL vials in February 2013.
- Hospira has sodium chloride 14.6% and 23.4% solutions for injection on shortage due to manufacturing delays. Hospira discontinued sodium chloride 14.6% solution 250 mL vials in February 2011.
Available Products
Sodium Chloride 23.4% Solution for Injection
Sodium Chloride 23.4%, APP
30 mL vials (NDC 63323-0187-30)
Sodium Chloride 14.6% Solution for Injection
Sodium Chloride 14.6%, APP
40 mL vials (NDC 63323-0139-40)
Estimated Resupply Dates
Sodium Chloride 23.4% Solution for Injection
- APP has sodium chloride 23.4% solution in 100 mL vials on intermittent back order and the company is releasing supplies as they become available. The 200 mL vials are on back order with an estimated release date in late-May 2013.
- American Regent has sodium chloride 23.4% solution on back order and the company cannot estimate a release date.
- Hospira has sodium chloride 23.4% solution in 100 mL and 250 mL bulk glass containers on back order and the company cannot estimate a release date.
Sodium Chloride 14.6% Solution for Injection
- Hospira has sodium chloride 14.6% solution for injection 20 mL and 40 mL vials on back order and the company estimates a release date of 3rd quarter 2013.
Related Shortages
Updated
May 10, 2013; March 29, 2013; February 22, 2013; January 8, 2013; December 10, 2012; December 4, 2012; November 15, 2012; October 24, 2012; October 17, 2012; October 15, 2012; September 27, 2012; August 8, 2012; June 28, 2012; May 15, 2012; May 2, 2012; April 4, 2012; March 20, 2012; March 7, 2012; February 23, 2012; February 1, 2012; January 18, 2012; January 12, 2012, 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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