Products Affected - Description

• • Epinephrine injection, Pfizer, 0.1 mg/mL, 10 mL 20 gauge Luer Lock syringe, 10 count, NDC 00409-4933-01

Reason for the Shortage

• • Amphastar has epinephrine available. Their epinephrine is still a grandfathered product.[1]
  • Pfizer has recently received FDA approval for their epinephrine 0.1 mg/mL 10 mL syringes. These have had a recent NDC change since the previous product was a grandfathered item.[2]
  • BPI has epinephrine 1 mg/mL 2 mL ampules available.[3]
  • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]

Available Products

• • Adrenalin injection, Par Sterile Products, 1 mg/mL, 1 mL vial, 25 count, NDC 42023-0159-25
  • Adrenalin injection, Par Sterile Products, 1 mg/mL, 30 mL multiple dose vial, 1 count, NDC 42023-0168-01
  • Epinephrine injection, Amphastar, 0.1 mg/mL, 10 mL syringe, 10 count, NDC 76329-3318-01
  • Epinephrine injection, Amphastar, 1 mg/mL, 30 mL vial, 1 count, NDC 76329-9060-00
  • Epinephrine injection, BPI Labs, 0.1 mg/mL, 10 mL syringe, 10 count, NDC 54288-0155-10
  • Epinephrine injection, BPI Labs, 1 mg/mL, 10 mL vial, 1 count, NDC 54288-0120-01
  • Epinephrine injection, BPI Labs, 1 mg/mL, 2 mL containing 1 mL sulfite-free and preservative-free ampule, 10 count, NDC 54288-0103-10

• • Pfizer has epinephrine 0.1 mg/mL 10 mL Luer-Lock syringes on back order and the company estimates a release date of July 2024.[2]

• • Epinephrine emergency syringes are commonly used for treatment of ventricular fibrillation or pulseless ventricular tachycardia unresponsive to initial defibrillatory shocks, pulseless electrical activity, and asystole.[5-6]

• • Epinephrine is a high alert medication and may cause significant patient harm when used in error.[6]
  • Create a dose conversion chart reflecting available epinephrine concentrations to keep in code boxes and post in areas where epinephrine is frequently used.[7]
  • Do not stock the 30 mL multi-dose vials in code boxes.[7]
  • Routine bulk compounding is not an option due to epinephrine having a short stability time and sensitivity to pH, light, and air.[7]

• • Consider conserving current supplies of epinephrine emergency syringes for code boxes or code situations.
  • Consider limiting the number of emergency syringes that are stocked in the code boxes.[7]

• 1. Amphastar (personal communications). May 3 and 30, 2017; April 26, August 12, 2019; April 29, July 21 and 31, December 14, 2020; June 1, December 13, 2021; July 28, November 30, 2022; February 27, and October 23, 2023.
  2. Pfizer (personal communications and website). May 3 and 26, June 2 and 14, July 6, August 4 and 28, September 29, November 7 and 15, December 1 and 8, 2017; January 6, February 9 and 20, March 9, May 11, June 29, August 10 and 30, September 28, November 1, December 7, 2018; January 31, March 1 and 29, April 26, May 31, June 3, August 30, September 13, November 1, December 3, 2019; January 3, February 20, March 27, July 20 and 31, August 28, December 11, 2020; March 10, May 28, December 3, 2021; March 25, June 13, August 7, September 30, November 11, December 9, 2022; February 12, March 10 and 24, May 1 and 12, July 14 and 25, October 23, 2023; January 29, and April 22, 2024.
  3. BPI Labs. May 3 2017; and July 25, 2023.
  4. Par Pharmaceuticals. May 3, and June 12, 2017; and January 24, 2018.
  5. Epinephrine Injection product information. Lake Forest, IL: Hospira; 2016 March.
  6. Epinephrine. Lexi-Comp Online. Hudson, OH: Lexi-Comp Inc.; 2017.
  7. Institute for Safe Medication Practices. EPINEPHrine pre-filled syringe shortage. https://www.ismp.org/NAN/files/NAN-201006.pdf . Accessed May 31, 2017.