Products Affected - Description

• • Infumorph (preservative-free) injection, Hikma, 25 mg/mL, 20 mL ampule, 1 count, NDC 00641-6040-01
  • Morphine injection, Fresenius Kabi, 4 mg/mL, 1 mL vial, 25 count, NDC 63323-0454-01
  • Morphine injection, Pfizer, 1 mg/mL, 10 mL preservative-free vial, 25 count, NDC 00409-3815-12
  • Morphine injection, Pfizer, 50 mg/mL, 20 mL vial, 50 count, NDC 00409-1134-03 - discontinued
  • Morphine injection, Pfizer, 50 mg/mL, 20 mL vial, 50 count, NDC 00409-1896-20
  • Morphine injection, Pfizer, 50 mg/mL, 50 mL vial, 50 count, NDC 00409-1134-05

Reason for the Shortage

• • Fresenius Kabi has morphine injection available.[1-2]
  • Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.[2]
  • Hikma has morphine injection on shortage due to increased demand.[3]
  • Pfizer has morphine injection on shortage due to manufacturing delay. Pfizer changed NDCs of the morphine 50 mg/mL 20 mL vials in late-2023.[4]
  • Piramal Critical Care has Mitigo available.[5]

Available Products

• • Duramorph (preservative-free) injection, Hikma, 0.5 mg/mL, 10 mL ampule, 10 count, NDC 00641-6020-10
  • Duramorph (preservative-free) injection, Hikma, 1 mg/mL, 10 mL ampule, 10 count, NDC 00641-6019-10
  • Infumorph (preservative-free) injection, Hikma, 10 mg/mL, 20 mL ampule, 1 count, NDC 00641-6039-01
  • Mitigo injection, Piramal Critical Care, 10 mg/mL, 20 mL preservative-free vial, 1 count, NDC 66794-0160-02
  • Mitigo injection, Piramal Critical Care, 25 mg/mL, 20 mL preservative-free vial, 1 count, NDC 66794-0162-02
  • Morphine injection, Fresenius Kabi, 10 mg/mL, 1 mL vial, 25 count, NDC 63323-0451-01
  • Morphine injection, Fresenius Kabi, 2 mg/mL, 1 mL preservative-free prefilled syringe, 10 count, NDC 76045-0004-11
  • Morphine injection, Fresenius Kabi, 2 mg/mL, 1 mL vial, 25 count, NDC 63323-0452-01
  • Morphine injection, Fresenius Kabi, 4 mg/mL, 1 mL preservative-free prefilled syringe, 10 count, NDC 76045-0005-11
  • Morphine injection, Fresenius Kabi, 5 mg/mL, 1 mL vial, 25 count, NDC 63323-0455-01
  • Morphine injection, Fresenius Kabi, 8 mg/mL, 1 mL vial, 25 count, NDC 63323-0458-01
  • Morphine injection, Hikma, 10 mg/mL, 1 mL vial, 25 count, NDC 00641-6127-25
  • Morphine injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6125-25
  • Morphine injection, Hikma, 8 mg/mL, 1 mL vial, 25 count, NDC 00641-6126-25
  • Morphine injection, Pfizer, 0.5 mg/mL, 10 mL preservative-free vial, 25 count, NDC 00409-3814-12
  • Morphine injection, Pfizer, 10 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1893-01
  • Morphine injection, Pfizer, 10 mg/mL, 1 mL preservative-free NexJect syringe, 10 count, NDC 00409-1893-23
  • Morphine injection, Pfizer, 2 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1890-01
  • Morphine injection, Pfizer, 2 mg/mL, 1 mL preservative-free NexJect syringe, 10 count, NDC 00409-1890-23
  • Morphine injection, Pfizer, 4 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1891-01
  • Morphine injection, Pfizer, 4 mg/mL, 1 mL preservative-free NexJect syringe, 10 count, NDC 00409-1891-23
  • Morphine injection, Pfizer, 8 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1892-01

• • Fresenius Kabi has morphine 2 mg/mL 1 mL vials and 4 mg/mL 1 mL vials on back order and the company estimates a release date of early-December 2024 for the 2 mg/mL 1 mL vials and mid- to late-November 2024 for the 4 mg/mL 1 mL vials.[2]
  • Hikma has Infumorph 25 mg/mL 20 mL ampules on back order and the company estimates a release date of early-December 2024.[3]
  • Pfizer has morphine 50 mg/mL 20 mL vials on back order and the company estimates a release date of March 2025. The 50 mg/mL 50 mL vials are on back order and the company cannot estimate a release date. The 1 mg/mL 10 mL preservative-free vials are available in limited supply.[4]

• • ASHP has an FAQ on the injectable opioid shortage at https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. This discusses multiple issues including inventory and pharmacy operational strategies

• • Exercise extreme caution when switching morphine concentrations or interchanging to other injectable opioid products (eg, hydromorphone). Equianalgesic dosing conversions are based on limited data and do not account for patient specific factors (eg, end organ function, pharmacogenomics) or incomplete cross-tolerance between opioids. No equianalgesic dosing conversion factors are universally accepted.[6-7]

• • Use oral opioid dosage forms if the enteral route is available.[8]
  • Use patient controlled analgesia (PCA) presentations or prepare PCAs from multidose vials to conserve unit dose presentations. Patient controlled analgesia is the preferred method of parenteral opioid administration in postoperative patients.[8]
  • Work with prescribers to convert to an appropriate dose of another parenteral opioid if needed and available.

• 1. BD (personal communications). October 2, 2015.
  2. Fresenius Kabi (personal communication). May 6 and 23, June 8, August 1 and 18, September 21, October 6, November 7, December 19, 2016; January 24, April 24, June 2, July 6 and 19, August 10, September 7, 21, and 28, October 27, November 10, 17, and 30, December 10, 15, and 17, 2017; January 12, February 5 and 15, March 2, 16, and 23, April 6 and 13, May 3, 10, and 19, June 4, 7, and 18, July 12 and 27, August 17 and 29, September 6, 14, 21, and 28, October 5, 12, 20, and 26, November 2, 9, 16, and 29, December 9, 20, and 27, 2018; January 11 and 18, February 1 and 21, March 1, 15, and 29, April 26, May 3, 11, and 24, June 27, July 5, 12, and 18, August 2, 16, 26, and 30, and September 6 and 27, November 1, 15, and 22, December 2, 2019; January 2 and 17, February 14 and 28, March 13, May 1 and 29, July 10, August 7, September 4, December 4 and 23, 2020; January 15 and 29, March 12, April 16, May 14 and 28, June 11, July 8 and 30, August 20 and 27, September 24, October 15, November 12 and 19, December 10 and 17, 2021; January 7, 14, and 28, February 18, March 4, April 14, June 3, August 5 and 26, September 16, November 11 and 18, December 2, 16, and 29, 2022; January 13 and 20, February 10, March 3, 10, 17, and 31, April 7 and 21, May 5 and 26, June 2, 9, 23, and 30, July 27, August 31, September 8, 14, and 22, October 5, November 2, 2023; January 4 and 18, February 29, March 7 and 28, May 9, July 5 and 18, August 22, September 19, October 24 and 31, and November 15, 2024.
  3. Hikma (personal communication). August 12 and 26, September 15 and 30, October 1 and 15, November 30, December 14, 2015; January 6 and 28, February 18 and 28, March 29, April 11, May 3, 13, and 24, June 17, August 1 and 10, September 29, November 2, December 19, 2016; January 25, February 24, May 3, June 7, July 5 and 19, August 10, September 6, 22, and 29, October 27, November 9, 22, and 30, December 7, 14, and 20, 2017; January 5 and 18, February 1, 14, and 28, March 21, April 4 and 18, May 2, 10, and 16, June 6 and 20, July 11, August 1, 15, and 29, September 5, 12, 19, and 28, October 3, 10, 17, 24, and 31, November 7, 14, and 28, December 12 and 20, 2018; January 16, 23, and 30, February 27, March 6, 13, and 27, April 24, May 2, 8, and 29, June 27, July 3, 10, 24, and 31, August 14 and 21, September 11, October 2 and 30, November 20 and 27, 2019; January 2 and 22, February 19 and 26, March 18, April 29, June 3, July 8, August 12, September 2, December 2 and 30, 2020; January 13 and 27, March 10, April 21, May 12, June 2 and 9, July 14 and 28, August 18 and 25, September 22, October 20, November 10 and 17, December 1, 10, and 22, 2021; January 12 and 26, February 16, March 2, April 13, June 8, August 10 and 24, September 14, November 9 and 22, December 1 and 22, 2022; January 4, 12, and 18, February 8, March 2, 8, 15, and 29, April 6 and 20, May 3 and 25, June 2, 8, 22, and 29, July 26, August 30, September 6, October 4, November 1, 2023 January 3 and 17, February 28, March 6 and 27, May 8, July 3 and 17, August 21, September 18, October 23 and 30, and November 13, 2024.
  4. Pfizer (personal communication and website). September 4 and 18, October 2 and 19, November 17 and 30, December 17 and 23, 2015; January 14, February 22, April 11, May 4, 10, 18, and 25, June 2, 17, and 23, August 1 and 25, September 6, October 8, November 10, December 19, 2016; January 24, February 22 and 24, May 4, June 2, 9, and 21, July 7, 25, and 31, August 11, September 6, 11, and 25, October 4, November 2, 15, and 28, December 5, 11, and 29, 2017; January 5 and 18, February 2 and 16, March 5, 16, and 23, April 9 and 20, May 4, 11, and 18, June 5 and 21, July 16 and 31, August 17 and 29, September 7, 14, 21, and 28, October 5, 16, 19, and 25, November 2, 9, 16, and 30, December 12 and 20, 2018; January 15 and 25, February 1 and 28, March 6 and 14, April 1, 24, 30, May 15 and 28, June 28, July 3, 12, and 26, August 2, 16, and 23, September 10, October 1, November 4 and 25, December 5, 2019; January 7 and 24, February 20 and 28, March 20, May 5, June 3, July 10, August 12, September 4, December 4, 2020; January 5, 18, and 31, March 12, April 16, May 14 and 28, June 11, July 13 and 30, August 24 and 31, September 24, October 20, November 12, December 1, 10, and 27, 2021; January 11, 16, and 28, February 21, March 4, April 18, June 8, August 10 and 29, September 16, November 11 and 27, December 5 and 22, 2022; January 6,17, and 24, February 12, March 3, 13, 17, and 31, April 9 and 23, May 9 and 26, June 4, 9, 26, and 30, August 1, September 4, 8, and 22, October 6, November 3, 2023; January 5 and 22, March 1, 12, and 29, May 14, July 9 and 19, August 26, September 22, October 29, and November 1 and 15, 2024.
  5. Piramal Critical Care (personal communications). April 27, 2019; February 20, May 1, July 14, December 7, 2020; January 6, and April 22, May 10, June 2, August 6 and 26, 2021; January 17, July 20, November 14, December 21, 2022; March 6, May 26, November 8, 2023; March 18, July 9, and October 31, 2024.
  6. Fishman SM, Ballantyne JC, Rathmell JP, eds. Bonica's Management of Pain. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010.
  7. McPherson ML, ed. Demystifying Opioid Conversion Calculations. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
  8. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131-157.