[19 April 2013]
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 recently upgraded their manufacturing plant. Product will become available in stages as production resumes.
- Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis. Product is becoming available in stages as production resumes. Availability of products is updated on the Bedford Laboratories website.
- 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 back order and the company cannot estimate a release date. Production is pending as capacity permits.
- Teva has levocarnitine injection on back order and the company cannot estimate a release date.
April 19, 2013; February 13, 2013; December 12, 2012; October 12, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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