[10 April 2013]
Products Affected - Description
Nicardipine hydrochloride injection, Caraco
2.5 mg/mL, 10 mL ampules (NDC 41616-0882-44)
Nicardipine hydrochloride injection, Teva
2.5 mg/mL, 10 mL vials (NDC 00703-8315-03) - discontinued
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)
Reason for the Shortage
- 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 had an NDC number change in November, 2012.
Available Products
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)
Nicardipine hydrochloride injection, Wockhardt
2.5 mg/mL, 10 mL vials (NDC 64679-0631-02)
Cardene, 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)
Nicardipine hydrochloride injection, West-Ward
2.5 mg/mL, 10 mL vials (NDC 00143-9689-10)
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 estimates a release date in May 2013.
- Cornerstone Therapeutics has Cardene injection 2.5 mg/mL 10 mL ampules on back order and the company cannot estimate a release date.
Related Shortages
Updated
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 2013, University of Utah, Drug Information Service.
Disclaimer
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