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Nicardipine Hydrochloride Injection

[03 February 2016]

Products Affected - Description

Cardene injection, Chiesi (formerly Cornerstone Therapeutics)
2.5 mg/mL, 10 mL ampule (NDC 24477-0030-25) - discontinued
 
Nicardipine hydrochloride injection, Caraco
2.5 mg/mL, 10 mL ampule, 10 count (NDC 41616-0882-44)
 
Nicardipine hydrochloride injection, Sandoz
2.5 mg/mL, 10 mL vial, 10 count (NDC 00781-3204-95)
 
Nicardipine Hydrochloride injection, West-Ward
2.5 mg/mL, 10 mL vial, 10 count (NDC 00143-9689-10)

Reason for the Shortage

  • American Regent has never started manufacturing nicardipine injection.
  • Caraco has temporarily discontinued nicardipine injection and it is unclear if product will return.
  • Chiesi acquired Cornerstone Therapeutics and changed the companies name in 2014. Cardene ampules were discontinued in March 2014.
  • Mylan Institutional has had nicardipine injection temporarily unavailable since 2013 and it is unclear if product will return.
  • Sandoz has had nicardipine injection temporarily unavailable since 2013 and it is unclear if product will return.
  • Wockhardt has nicardipine on shortage due to an FDA import alert. It is unclear if product willreturn.

Available Products

Cardene injection, Chiesi
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

West-Ward is allocating nicardipine injection weekly.

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

February 3, 2016; November 18, September 2, July 30, June 1, March 2, 2015; December 1, September 15, July 22 and 2, May 30 and 1, March 3, February 21, January 17, 2014; December 27 and 4, October 25, September 26, 23 and 12, August 22 and 1, June 28, May 31, April 10, March 14, February 7, 2013; December 12, September 6, June 29, February 15, January 20, 2012; November 18, September 21, August 11, June 9, April 27, March 30, January 21, 2011; November 12, October 1, September 15, July 30, June 8, May 5, March 19, February 22, January 12, 2010; November 6, September 21, August 6, June 9, April 20, March 9, February 18, January 12, 2009; December 2, November 10, October 17, 2008, University of Utah, Drug Information Service. Copyright 2016, 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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