[15 May 2013]
Products Affected - Description
Use in Paroxysmal Supraventricular Tachycardia
Adenosine Injection, 3 mg/mL, Bedford
2 mL vial, 10 count (NDC 55390-0067-10)
4 mL vial, 1 count (NDC 55390-0068-01)
Adenosine Injection, 3 mg/mL, Wockhardt
4 mL syringe, 10 count (NDC 64679-0630-08) - discontinued
Reason for the Shortage
- Akorn launched adenosine 3 mg/mL 2 mL vials 25 count in April 2013.
- Astellas had Adenoscan on back order due to increased demand. Adenoscan is used for diagnostic purposes as an adjunct to thallium-201 myocardial perfusion scintigraphy. Adenocard and generic adenosine products are labeled for use in paroxysmal supraventricular tachycardia.
- 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.
- Teva has discontinued their adenosine injection.
- Wockhardt discontinued their adenosine 3 mg/mL 4 mL syringes.
Available Products
Diagnostic Adjunct
Adenoscan Injection, 3 mg/mL, Astellas
30 mL vial (NDC 00469-0871-30)
20 mL vial (NDC 00469-0871-20)
Use in Paroxysmal Supraventricular Tachycardia
Adenocard Injection, 3 mg/mL, Astellas
2 mL vial (NDC 00469-0872-02)
2 mL prefilled syringe (NDC 00469-8234-12)
4 mL prefilled syringe (NDC 00469-8234-14)
Adenosine Injection, 3 mg/mL, Akorn
2 mL vial, 10 count (NDC 17478-0542-02)
2 mL vial, 25 count (NDC 17478-0542-25)
Adenosine Injection, 3 mg/mL, APP
2 mL vial, 10 count (NDC 63323-0651-02)
4 mL vial, 10 count (NDC 63323-0651-04)
Adenosine Injection, 3 mg/mL, Sagent
2 mL prefilled syringe, 10 count (NDC 25021-0301-76)
4 mL prefilled syringe, 10 count (NDC 25021-0301-72)
2 mL vial, 10 count (NDC 25021-0301-02)
4 mL vial, 10 count (NDC 25021-0301-04)
Adenosine Injection, 3 mg/mL, West-Ward
2 mL vial, 10 count (NDC 00641-6113-10)
Adenosine Injection, 3 mg/mL, Wockhardt
2 mL syringe, 10 count (NDC 64679-0630-07)
Estimated Resupply Dates
Use in Paroxysmal Supraventricular Tachycardia
- Bedford has adenosine 2 mL and 4 mL vials on long-term back order and will not be manufactured until capacity permits.
Related Shortages
Updated
May 15, 2013; May 13, 2013; April 11, 2013; March 13, 2013; March 1, 2013; February 13, 2013; January 25, 2013; December 28, 2012; December 21, 2012; November 19, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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