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 vial, 25 count (NDC 00517-3900-25)
Calcium gluconate intravenous injection, Fresenius Kabi
100 mg/mL, 10 mL plastic vial, 25 count (NDC 63323-0311-19)
100 mg/mL, 50 mL plastic vial, 25 count (NDC 63323-0311-59)
100 mg/mL, 100 mL plastic vial, 40 count (NDC 63323-0311-66)
Reason for the Shortage
- American Regent has calcium gluconate on shortage due to manufacturing delays.
- Fresenius Kabi has calcium gluconate available with alternating short-dating due to manufacturing process of the 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 50 mL vials available with an expiration date of <8 months. The 10 mL vials and 100 mL vials are on back order and the company estimates a release date of late-February 2017.
February 22, January 10, 2017; December 20, November 22, October 31, September 26, August 13 and 5, July 19, June 21 and 9, May 12, April 6, February 24, January 25 and 6, 2016; December 11 and 3, November 5, September 25, August 19, June 15, April 16, March 13, February 3, January 16, 2015; December 12, November 14, October 13, September 18, 10 and 3, August 1, July 21, June 4, May 21 and 1, March 28 and 3, February 10, January 21, 2014; December 13, October 28, September 12 and 3, August 13 and 1, July 11, June 18, May 23, April 22, 10 and 1, March 25, February 21, January 2, 2013; December 10, November 19, 2012, University of Utah, Drug Information Service. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.
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