Products Affected - Description

• • Sodium Bicarbonate injection, Amphastar, 8.4%, 50 mL syringe, 10 count, NDC 76329-3352-01
  • Sodium Bicarbonate injection, Pfizer, 4.2%, 10 mL LifeShield syringe, 10 count, NDC 00409-5534-14
  • Sodium Bicarbonate injection, Pfizer, 4.2%, 5 mL vial, 25 count, NDC 00409-5555-02
  • Sodium Bicarbonate injection, Pfizer, 7.5%, 50 mL LifeShield syringe, 10 count, NDC 00409-4916-14
  • Sodium Bicarbonate injection, Pfizer, 8.4%, 10 mL syringe, 10 count, NDC 00409-4900-14
  • Sodium Bicarbonate injection, Pfizer, 8.4%, 50 mL LifeShield syringe, 10 count, NDC 00409-6637-14
  • Sodium Bicarbonate injection, Pfizer, 8.4%, 50 mL vial, 25 count, NDC 00409-6625-14

Reason for the Shortage

• • Amphastar has sodium bicarbonate injection on shortage due to increased demand.[1]
  • Athenex is no longer marketing sodium bicarbonate.[2]
  • Exela has sodium bicarbonate injection available.[3]
  • Fresenius Kabi has sodium bicarbonate injection available.[4]
  • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.[5]

Available Products

• • Sodium Bicarbonate injection, Exela Pharma Sciences, 4.2%, 10 mL vial, 25 count, NDC 51754-5012-04
  • Sodium Bicarbonate injection, Exela Pharma Sciences, 8.4%, 10 mL vial, 25 count, NDC 51754-5011-04
  • Sodium Bicarbonate injection, Exela Pharma Sciences, 8.4%, 50 mL vial, 25 count, NDC 51754-5001-04
  • Sodium Bicarbonate injection, Fresenius Kabi, 4.2%, 5 mL vial, 25 count, NDC 63323-0083-05
  • Sodium Bicarbonate injection, Fresenius Kabi, 8.4%, 50 mL vial, 25 count, NDC 63323-0089-50

• • Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation.[1]
  • Pfizer has 7.5% sodium bicarbonate 50 mL syringes on back order and the company estimates a release date of November 2024. The 8.4% sodium bicarbonate 10 mL syringes, 50 mL vials, and 50 mL syringes are on back order and the company estimates a release date of June 2024 for the 10 mL syringes and 50 mL vials and April 2024 for the 50 mL syringes. The 4.2% sodium bicarbonate 10 mL syringes are on back order and the company estimates a release date of October 2024. The 4.2% sodium bicarbonate 5 mL vials are available for emergency use via direct orders.[5]

• • Sodium bicarbonate injection is commonly used in critical care settings during advanced cardiac life support (ACLS). The product is also used to manage metabolic acidosis and hyperkalemia and to increase urinary pH. Sodium bicarbonate injection may be used as an antidote for selected products such as tricyclic antidepressants, methyl alcohol, phenobarbital, or salicylates.[6-7]
  • Some centers have used the injectable product to prepare extemporaneous oral solutions of omeprazole or lansoprazole.[8]

• • Few alternatives are available. Clinicians should make every effort to reserve supplies for critical care uses.
  • If using sodium acetate as an alternative, infuse the product over 15 to 20 minutes rather than 1 to 2 minutes with sodium bicarbonate.[10]
  • When drawing up doses from vials, ensure appropriate sterility measures are taken following USP <797> recommendations for batching.
  • Pfizer has issued a recall on 42 lots of sodium bicarbonate 8.4% 50 mL vials and Neut 4% additive solution due to sterility concerns. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563382.htm

• • Conserve sodium bicarbonate for critical uses. Avoid using product for non-essential purposes such as buffering lidocaine during this shortage. The Society of Critical Care Medicine (SCCM) has recommendations for conserving sodium bicarbonate. http://www.learnicu.org/Lists/Web%20Contents/Attachments/14258/Drug-Shortages-Alert-9-16.pdf.
  • Evaluate vial use and consider methods to conserve supplies such as drawing up doses from vials rather than wasting unused product. Review storage locations such as crash carts and reduce inventory where possible.
  • If purchasing premade Continuous Renal Replacement Therapy (CRRT) solutions, consider those with higher sodium bicarbonate concentrations.
  • Sodium acetate injection may be an appropriate substitute for toxicology emergencies. The initial dose for salicylate overdose, severe cardiac arrhythmias, and initial rapid treatment of QRS widening is 1 mEq per kg body weight infused over 15 to 20 minutes with a goal serum pH of 7.5 to 7.55. Maintenance infusions are sodium acetate 150 mEq in 1 L 5% dextrose.[10]
  • Prepare oral solutions of omeprazole or lansoprazole using a sodium bicarbonate solution prepared from baking soda (1 teaspoon baking soda dissolved in 240 mL water).[9]
  • Oral sodium bicarbonate 650-mg tablets (Rising Pharmaceuticals, NDC 64980-0294-10) may be an appropriate alternative for urine alkalinization in patients receiving high-dose methotrexate.[11]

• 1. Amphastar (personal communications). February 17, May 4, 2017; April 20, August 15, 2018; May 13, August 12, September 9, 2019; February 12, May 14, July 6, 21, and 31, December 14, 2020; June 1, 2021; January 11, February 28, May 16, July 28, November 30, 2022; February 8, April 10, August 28, October 20, 2023; January 3, and February 27, 2024.
  2. Athenex (personal communications). August 1, September 9, 2019; January 7, February 12, and July 7, 2020.
  3. Exela (personal communications). April 8, October 11, 2020; January 19, December 13, 2021; April 20, July 19, August 15, October 12, December 6, 2022; February 14, May 17, July 31, September 5, October 9 and 30, November 14, 2023; January 3 and 31, February 12, and April 3, 2024.
  4. Fresenius Kabi (personal communications). July 25 and 27, September 15 and 28, October 27, November 10, and December 22, 2017; January 26, February 5, March 16, April 13, June 25, August 13 and 29, September 11 and 24, October 5 and 20, November 2, 16, 23, and 29, December 27, 2018; January 11, February 7, 15, and 21, March 1, 21, and 29, April 19, May 3, 11, and 30, June 21 and 27, July 5,12, and 26, August 12, 16, 26, and 30, September 16 and 27, November 1 and 15, 2019; January 10, February 11 and 28, April 3, May 1 and 29, July 2, 17, and 24, October 9, December 11, 2020; January 15 and 22, February 26, March 19, April 30, May 7, June 11, July 8, September 3 and 17, November 12, December 10, 2021; January 14, February 18 and 25, March 11, April 8 and 22, May 6, June 3, July 15, August 12, September 2 and 23, October 21 and 28, November 11 and 18, December 2, 16, and 29, 2022; January 27, February 10, March 3, April 7 and 14, May 12, June 2 and 30, July 27, August 3 and 24, September 7, October 5, November 2, 9, and 16, 2023; January 4 and 18, February 8 and 22, March 14, and April 4, 2024.
  5. Pfizer (personal communications). February 17, March 13 and 21, April, 14, May 3, 18, and 19, June 9, 15, and 22, July 6, 14, 28, and 31, August 15, September 1 and 29, October 27, November 2 and 15, December 29, 2017; January 26, February 2, March 20, April 13 and 20, June 5 and 22, August 15 and 31, September 7, 11, 21, and 28, October 12 and 25, November 6 and 23, December 7 and 28, 2018; January 1 and 15, February 8, 15, and 19, March 1 and 25, April 3 and 19, May 3 and 15, June 5 and 26, July 2, 16, and 30, August 9, 20, 23, and 30, September 17 and 27, November 1 and 15, December 5, 2019; January 10, February 11 and 28, April 8, May 1 and 29, July 7 and 20, October 9, December 11, 2020; January 15, February 28, March 19, May 4, June 11, September 3 and 17, November 12, December 10, 2021; January 14, February 18 and 25, April 8 and 22, May 6, June 3, July 15, August 12, September 2 and 23, October 21 and 28, November 11 and 18, December 5 and 19, 2022; January 6, February 1 and 14, March 3, April 7 and 21, May 12, June 2 and 30, July 28, August 4, 3, and 25, September 8, October 6, November 3, 14, and 17, 2023; January 5 and 19, February 9 and 27, March 15, and April 5, 2024.
  6. Sodium Bicarbonate. In: Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology & Critical Care Drug Handbook, 10th ed. Hudson, OH: Lexi-Comp; 1444 - 1447.
  7. Sodium Bicarbonate. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2017 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2017:2852 - 2854.
  8. DiGiacinto JL, Olsen KM, Bergman KL, Hoie EB. Stability of Suspension Formulations of Lansoprazole and Omeprazole Stored in Amber-Colored Plastic Oral Syringes. Annals of Pharmacotherapy. 2000;34:600-605.
  9. Walters JK, Zimmermann AE, Souney PF, Katona BG. The Use of Omeprazole in the Pediatric Population. Annals of Pharmacotherapy.1998;32:478-481.
  10. Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium Acetate as a Replacement for Sodium Bicarbonate in Medical Toxicology: a Review. J Med Toxicol. 2013;9:250-254.
  11. Rouch JA, Burton B, Dabb A, et al. Comparison of Enteral and Parenteral Methods of Urine Alkalinization in Patients Receiving High-Dose Methotrexate. J Oncol Pharm Practice. 2017;23:3-9.