Products Affected - Description
L-cysteine hydrochloride injection, American Regent
50 mg/mL, 10 mL vial, 25 count (NDC 00517-2050-05)
50 mg/mL, 50 mL vial, 5 count (NDC 00517-2064-25)
Reason for the Shortage
- American Regent has L-cysteine hydrochloride injection on back order due to manufacturing delays.
- Sandoz has L-cysteine hydrochloride injection available.
L-cysteine hydrochloride injection, Sandoz
50 mg/mL, 10 mL vial, 10 count (NDC 66758-0004-02)
50 mg/mL, 50 mL vial, 5 count (NDC 66758-0005-02)
Estimated Resupply Dates
American Regent has L-cysteine hydrochloride injection 10 mL and 50 mL vials on back order and the company cannot estimate a release date.
Alternative Agents & Management
The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations
for managing this shortage.
Key recommendations include:
- Reserve supplies for neonatal patients <1 kg or neonatal patient who are >1 kg after surgery or with sepsis.
- Avoid use of L-cysteine if patient is receiving at least 3 gram/kg per day of protein.
- Consider oral or enteral routes for supplementation if possible.
- Avoid using L-cysteine for catheter patency.
- Compound in central location and add L-cysteine as a separate product from amino acid solutions to help conserve supplies.
- Purchase only the supply needed, do not stockpile.
May 3, March 8, February 16, 2016; November 3, October 23, 12 and 5, September 21 and 10, June 25 and 5, May 27 and 8, April 27, March 9, February 12, January 26, 2015; December 31 and 12, November 25, 2014, University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.
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