[17 April 2013]
Products Affected - Description
Enalaprilat Injection, Bedford
1.25 mg/mL, 1 mL vial (NDC 55390-0010-10)
1.25 mg/mL, 2 mL vial (NDC 55390-0011-10)
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 multiple products for Bedford Laboratories, a division of Ben Venue.
- Teva has discontinued both of their products.
Enalaprilat Injection, Hospira
1.25 mg/mL, 1 mL vial (NDC 00409-2122-01)
1.25 mg/mL, 2 mL vial (NDC 00409-2122-02)
1.25 mg/mL, 1 mL vial (NDC 00409-2122-13)
1.25 mg/mL, 2 mL vial (NDC 00409-2122-88)
Enalaprilat Injection, West-Ward
1.25 mg/mL, 1 mL vial (NDC 00143-9787-10)
1.25 mg/mL, 2 mL vial (NDC 00143-9786-10)
Estimated Resupply Dates
Bedford has enalaprilat 1.25 mg/mL injection in 1 mL and 2 mL vials on long-term back order and will not be manufacturing this product until capacity permits.
April 17, 2013; February 21, 2013; December 21, 2012; November 27, 2012; October 30, 2012; September 18, 2012; July 12, 2012; July 5, 2012; May 24, 2012; May 2, 2012; April 11, 2012; March 6, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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