[20 May 2013]
Products Affected - Description
Caffeine citrate injection
Caffeine citrate injection, American Regent
20 mg/mL, 3 mL vial (NDC 00517-0020-10)
Caffeine citrate injection, APP
20 mg/mL, 3 mL vial (NDC 63323-0407-03)
Reason for the Shortage
- American Regent had temporarily suspended manufacture of most drug products in April, 2011.
- American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
- APP has caffeine citrate on shortage due to increased demand.
- Bedford had caffeine citrate on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
- Sagent launched caffeine citrate in the latter half of 2012.
Available Products
Caffeine citrate injection
Cafcit injection, Bedford
20 mg/mL, 3 mL vial (NDC 55390-0357-03)
Caffeine citrate injection, Caraco
20 mg/mL, 3 mL vial (NDC 47335-0289-40)
Caffeine citrate injection, Paddock
20 mg/mL, 3 mL vial (NDC 00574-0823-01)
20 mg/mL, 3 mL Novaplus vial (NDC 00574-0823-81)
Caffeine citrate injection, Sagent
20 mg/mL, 3 mL vial (NDC 25021-0601-03)
Caffeine citrate oral solution
Caffeine citrate oral solution, APP
20 mg/mL oral solution, 3 mL vial (NDC 63323-0406-03)
Cafcit oral solution, Bedford
20 mg/mL oral solution, 3 mL vial (NDC 55390-0358-03)
Caffeine citrate oral solution, Caraco
20 mg/mL oral solution, 3 mL vial (NDC 47335-0290-44)
Caffeine citrate oral solution, Paddock
20 mg/mL oral solution, 3 mL vial (NDC 00574-0152-10)
20 mg/mL oral solution, 3 mL Novaplus Vials (NDC 00574-0152-80)
Caffeine citrate oral solution, Sagent
20 mg/mL, 3 mL vial (NDC 25021-0602-03)
Estimated Resupply Dates
Caffeine citrate injection
- American Regent has caffeine citrate 20 mg/mL 3 mL vials for injection on back order and the company cannot estimate a release date.
- APP has caffeine citrate 20 mg/mL injection on back order and the company estimates a release date in mid- to late-June 2013.
Related Shortages
Updated
May 20, 2013; May 15, 2013; March 7, 2013; December 19, 2012; October 18, 2012; September 24, 2012; July 12, 2012; May 25, 2012; April 17, 2012; March 20, 2012; March 9, 2012; February 7, 2012; January 3, 2012; December 21, 2011; November 30, 2011; November 21, 2011; November 11, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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