L-Cysteine Hydrochloride Injection

[08 September 2016]

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)
L-cysteine hydrochloride injection, Sandoz
50 mg/mL, 10 mL vial, 10 count (NDC 66758-0004-02) - discontinued
50 mg/mL, 50 mL vial, 5 count (NDC 66758-0005-02) - discontinued

Reason for the Shortage

  • American Regent has L-cysteine hydrochloride injection on back order due to manufacturing delays.
  • Sandoz has discontinued L-cysteine hydrochloride 50 mL vials. The 10 mL vials (NDC 66758-0004-02) were replaced with new 10 mL vials (NDC 00781-8940-95).

Available Products

L-cysteine hydrochloride injection, Sandoz
50 mg/mL, 10 mL vial, 10 count (NDC 00781-8940-95)

Estimated Resupply Dates

American Regent has L-cysteine hydrochloride injection 10 mL and 50 mL vials on long-term 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.

Related Shortages


September 8, July 28, 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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