[22 March 2013]
Products Affected - Description
Diltiazem Injection, Bedford
5 mg/mL 5 mL vials (NDC 55390-0565-05)
5 mg/mL 25 mL vials (NDC 55390-0565-30)
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.
- Hospira had diltiazem injection on back order due to increased demand for the product.
- West-Ward changed NDC numbers in 1st quarter, 2012.
- Teva discontinued all diltiazem presentations in March, 2011.
- Biovail discontinued Cardizem Lyo-Ject in 2007 due to business reasons.
- Akorn launched diltiazem 5 mL and 10 mL vials in early-April, 2012.
Available Products
Diltiazem Injection, Akorn
5 mg/mL 5 mL vials (NDC 17478-0937-05)
5 mg/mL 10 mL vials (NDC 17478-0937-10)
5 mg/mL, 25 mL vials (NDC 17478-0937-25)
Diltiazem Injection, Hospira
5 mg/mL, 5 mL vials (NDC 00409-1171-01)
5 mg/mL, 10 mL vials (NDC 00409-1171-02)
100 mg ADD-Vantage vials (NDC 00409-4350-03)
Diltiazem Injection, West-Ward
5 mg/mL, 5 mL vials (NDC 00641-6013-10)
5 mg/mL, 10 mL vials (NDC 00641-6014-10)
5 mg/mL, 25 mL vials (NDC 00641-6015-10)
Diltiazem Injection, Bedford
5 mg/mL 10 mL vials (NDC 55390-0565-10)
Estimated Resupply Dates
Bedford has limited supplies of diltiazem 25 mL vials available for direct order or drop shipment. These vials are short-dated and have an expiration date of May 31, 2013. Diltiazem 5 mL vials are on long-term backorder and cannot estimate a release date.
Related Shortages
Updated
March 22, 2013; February 26, 2013; Febraury 22, 2013; January 3, 2013; November 28, 2012; October 22, 2012; September 26, 2012; August 17, 2012; July 13, 2012; June 28, 2012; May 18, 2012; May 10, 2012; April 20, 2012; April 10, 2012; April 4, 2012; March 14, 2012; February 16, 2012; February 3, 2012; January 18, 2012; December 7, 2011; November 28, 2011; November 21, 2011; November 16, 2011; November 9, 2011; October 31, 2011; October 27, 2011; October 12, 2011; September 30, 2011; September 20, 2011; August 31, 2011; August 26, 2011; August 24, 2011; August 3, 2011; July 22, 2011; July 20, 2011 July 1, 2011; June 29, 2011; June 1, 2011; May 11, 2011; May 2, 2011; April 18, 2011; April 11, 2011; March 29, 2011; March 14, 2011; March 1, 2011; February 17, 2011; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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