Products Affected - Description
Zinc sulfate, American Regent
1 mg/mL, 10 mL vial (NDC 00517-6110-25)
5 mg/mL, 5 mL vial (NDC 00517-8105-25)
Reason for the Shortage
- Hospira states the shortage of zinc chloride injection is due to manufacturing delays.
- Hospira is the only manufacturer of zinc chloride injection.
- 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.
- FDA is allowing temporary importation of zinc gluconate trihydrate 1 mg/mL 10 mL vials from Aguettant Laboratories in France. This product is being distributed through Baxter Healthcare. The labeling will come in the original container which is in French. Information translated into English along with a table comparing the US and French products can be found in the Dear Healthcare Professional Letter.
Zinc chloride, Hospira
1 mg/mL, 10 mL vial (NDC 00409-4090-01)
Zinc gluconate trihydrate, Aguettant (distributed through Baxter Healthcare)
1 mg/mL, 10 mL vial, 10 count size (NDC 60710-2320-01)
Estimated Resupply Dates
- American Regent has zinc sulfate 1 mg/mL 10 mL vials on back order and the company cannot estimate a release date. Zinc sulfate 5 mg/mL 5 mL vials are available in limited supply.
- Baxter Healthcare is distributing imported zinc gluconate 1 mg/mL 10 mL vials and product is available. Orders for zinc gluconate must be placed directly with Baxter's Center for Service by calling 1-888-229-0001, or email at CFS_Customer_Service@baxter.com.
Monitor patients for signs and symptoms of zinc deficiency. Pediatric patients are particularly susceptible. The Centers for Disease Control and Prevention (CDC) recently published reports of zinc deficiency in premature infants due to the nationwide shortage of zinc.
Alternative Agents & Management
The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage online
Key recommendations include:
- Reserve supplies for neonatal or pediatric patients or other vulnerable groups such as patients with short bowel or malabsorption syndromes.
- Avoid use of pediatric trace elements for adult patients.
- Adult trace element products are not recommended for pediatric patients.
- Consider oral or enteral multi-vitamin or multi-mineral products for supplementation if possible.
- Avoid using trace elements additives in IV fluids.
- Increase vigilance of signs and symptoms of trace element deficiencies. Symptoms of zinc deficiency may include dermatitis, impaired wound healing, alopecia, immune insufficiency, anorexia, growth failure, delayed sexual maturation, decreased taste sensitivity, and poor night vision.
- Purchase only the supply needed, do not stockpile.
June 6, 2014; April 25, 2014; April 3, 2014; February 26, 2014; January 27, 2014; December 10, 2013; November 25, 2013; October 31, 2013; September 26, 2013; August 29, 2013; August 1, 2013; July 9, 2013; May 28, 2013; May 20, 2013; May 9,2013; April 11, 2013; March 1, 2013; January 24, 2013; January 9, 2013; December 10, 2012; September 19, 2012; July 31, 2012; May 18, 2012; April 24, 2012; March 5, 2012; February 22, 2012; January 3, 2012; November 30, 2011; October 20, 2011; October 4, 2011; September 28, 2011; August 30, 2011; July 22, 2011; June 29, 2011; May 11, 2011; May 6, 2011; April 25, 2011; March 29, 2011; March 10, 2011; 2011; June 3, 2011; May 31, February 25, 2011; February 22, 2011; February 2, 2011; December 28, 2010; December 15, 2010, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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