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