Products Affected - Description
Calcium gluconate intravenous injection, American Regent
100 mg/mL, 50 mL vials, 25 count (NDC 00517-3950-25)
100 mg/mL, 100 mL vials, 25 count (NDC 00517-3900-25)
Calcium gluconate intravenous injection, Fresenius Kabi
100 mg/mL, 10 mL plastic vials, 25 count (NDC 63323-0311-19)
100 mg/mL, 50 mL plastic vials, 25 count (NDC 63323-0311-59)
100 mg/mL, 100 mL plastic vials, 40 count (NDC 63323-0311-66)
100 mg/mL, 10 mL vials, 25 count (NDC 63323-0311-10) - discontinued
100 mg/mL, 50 mL vials, 25 count (NDC 63323-0311-50) - discontinued
100 mg/mL, 100 mL vials, 40 count (NDC 63323-0311-61) - discontinued
Reason for the Shortage
- American Regent has calcium gluconate on shortage due to manufacturing delays.
- Fresenius Kabi has replaced calcium gluconate glass vials with plastic vials.
- American Regent has issued a statement that all lots of calcium gluconate may contain glass particles and filters must be used. Do not use if there are visible glass particles and filter all other product.
There is insufficient supply for usual ordering.
Estimated Resupply Dates
- American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.
- Fresenius Kabi has calcium gluconate 100 mg/mL 10 mL, 50 mL, and 100 mL vials on intermittent back order and the company is releasing product as it becomes available. Check wholesalers for inventory.
June 15, May 15, April 16, March 13, February 3, January 16, 2015; December 12, November 14, October 13, September 3, 10, 18, August 1, July 21, June 4, May 1 and 21, March 3 and 28, February 10, January 21, 2014; December 13, November 13, October 28, September 3 and 12, August 1 and 13, July 11, June 18, May 23, April 22, April 1 and 10, March 25, February 21, January 2, 2013; December 10, November 19, 2012, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.
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