[26 February 2014]
Products Affected - Description
Levocarnitine injection, American Regent
200 mg/mL, 5 mL vials (NDC 00517-1045-25)
Levocarnitine injection, Bedford
200 mg/mL, 5 mL vials (NDC 55390-0136-05)
Levocarnitine injection, Teva
200 mg/mL, 5 mL vials (NDC 00703-0404-02)
200 mg/mL, 12.5 mL vials (NDC 00703-0405-02)
Reason for the Shortage
- American Regent has levocarnitine injection on back order due to manufacturing delays.
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.
- Teva could not provide a reason for the shortage.
Carnitor injection, Sigma Tau
200 mg/mL, 5 mL vials (NDC 54482-0147-01)
Estimated Resupply Dates
- American Regent has levocarnitine injection on back order and the company cannot estimate a release date.
- Bedford has levocarnitine injection on long-term back order and the company cannot estimate when levocarnitine injection will be available again. This product was manufactured by Ben Venue.
- Teva has levocarnitine injection on back order and the company estimates a release date of 1st quarter 2015.
February 26, 2014; January 15, 2014; October 14, 2013; August 5, 2013; May 22, 2013; April 19, 2013; February 13, 2013; December 12, 2012; October 12, 2012, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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