Products Affected - Description
Zinc sulfate, American Regent
1 mg/mL, 10 mL vial (NDC 00517-6110-25)
Reason for the Shortage
- Hospira states the shortage of zinc chloride injection was due to manufacturing delays.
- Hospira is the only manufacturer of zinc chloride injection.
- American Regent states the shortage of zinc sulfate injection is due to manufacturing delays.
- FDA was allowing temporary importation of zinc gluconate trihydrate 1 mg/mL 10 mL vials from Aguettant Laboratories in France. This product was being distributed through Baxter Healthcare but the imported lots have expired and Baxter is not importing more product.
Zinc sulfate, American Regent
5 mg/mL, 5 mL vial (NDC 00517-8105-25)
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.
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.
March 24, February 2, 2015; December 16, October 7, August 7, June 6, April 3 and 25, February 26, January 8 and 27, 2014; December 10, November 25, October 25 and 31, September 26, August 1 and 29, July 9, May 9, 20, and 28, April 11, March 1, January 9 and 24, 2013; December 10, September 19, July 31, May 18, April 24, March 5, February 7 and 22, January 3 and 18, 2012; November 30, October 4 and 20, September 28, August 8 and 30, July 12 and 22, June 29, May 6 and 11, April 25, March 10 and 29, June 3 and 23, May 31, February 2, 22, and 25, 2011; December 15 and 28, 2010, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.
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