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Nicardipine Hydrochloride Injection

[22 July 2014]

Products Affected - Description

Nicardipine hydrochloride injection, Caraco
2.5 mg/mL, 10 mL ampules (NDC 41616-0882-44)
 
Nicardipine hydrochloride injection, Mylan Institutional
2.5 mg/mL, 10 mL vials (NDC 67457-0224-10)
 
Nicardipine hydrochloride injection, Sandoz
2.5 mg/mL, 10 mL vials (NDC 00781-3204-95)
2.5 mg/mL, 10 mL vials (NDC 00781-9324-95)

Nicardipine hydrochloride injection, American Regent
2.5 mg/mL, 10 mL vials (NDC 40042-0047-10)
 
Cardene, Cornerstone Therapeutics
2.5 mg/mL, 10 mL ampules (NDC 24477-0030-25) - discontinued
 
Nicardipine hydrochloride injection, Wockhardt
2.5 mg/mL, 10 mL vials (NDC 64679-0631-02)

Reason for the Shortage

  • Cornerstone Therapeutics discontinued Cardene ampules in March 2014. The company could not provide a reason for the discontinuation.
  • Teva recalled 4 lots nicardipine injection because the product did not meet purity specifications. The recalled lots are 31302508B, 31302510B, 31302957B, 31303195B.
  • Teva discontinued nicardipine injection in September, 2010.
  • American Regent had temporarily suspended distribution of all drug products in April, 2011.
  • American Regent resumed manufacturing in Shirely, New York in early-May, 2011.
  • Mylan Institutional could not provide a reason for the shortage.
  • Wockhardt has nicardipine on shortage due to an FDA import alert.

Available Products

Nicardipine hydrochloride injection, West-Ward
2.5 mg/mL, 10 mL vials (NDC 00143-9689-10)
 
Cardene, Chiesi (formerly Cornerstone Therapeutics)
40 mg/200 mL in 5% dextrose, 10 count (NDC 24477-0324-02)
40 mg/200 mL in 0.9% sodium chloride, 10 count (NDC 24477-0323-02)
20 mg/200 mL in 5% dextrose, 10 count (NDC 24477-0312-02)
20 mg/200 mL in 0.9% sodium chloride, 10 count (NDC 24477-0311-02)

Estimated Resupply Dates

  • American Regent has nicardipine hydrochloride injection on back order and the company cannot estimate a release date.
  • Caraco has nicardipine 2.5 mg/mL 10 mL ampules on back order and the company cannot estimate a release date.
  • Mylan Institutional has nicardipine on back order and the company cannot estimate a release date.
  • Sandoz has nicardipine 2.5 mg/mL 10 mL vials on back order and the company cannot estimate a release date.
  • Wockhardt has nicardipine 2.5 mg/mL 10 mL vials on back order and the company cannot estimate a release date.

Safety

West-Ward’s nicardipine hydrochloride injection 2.5 mg/mL 10 mL vials contain benzoic acid and sodium chloride as excipients compared to the Cardene 2.5 mg/mL 10 mL ampules and other generic nicardipine 2.5 mg/mL 10 mL vials and ampules, which contain citric acid and sorbitol as excipients.

Related Shortages

Updated

July 22, 2014; July 2, 2014; May 30, 2014; May 1, 2014; March 3, 2014; February 21, 2014; January 17, 2014; December 4, 2013; October 25, 2013; September 25, 2013; August 22, 2013; June 28, 2013; May 31, 2013; April 10, 2013; March 14, 2013; February 7, 2013; December 12, 2012; September 6, 2012; June 29, 2012; March 29, 2012; February 15, 2012; January 20, 2012; November 18, 2011; September 21, 2011; August 11, 2011; June 9, 2011; April 27, 2011; March 30, 2011; January 21, 2011; November 12, 2010; October 4, 2010; September 15, 2010; July 30, 2010; June 8, 2010; May 5, 2010; March 19, 2010; February 22, 2010; January 12, 2010; November 6, 2009; September 21, 2009; August 6, 2009; June 9, 2009; April 20, 2009; March 9, 2009; February 18, 2009; January 12, 2009; December 2, 2008; November 10, 2008; October 17, 2008,  University of Utah, Drug Information Service. Copyright 2014, University of Utah, Drug Information Service.

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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