Products Affected - Description

• • Marcaine solution for injection, Pfizer, 0.25%, 10 mL preservative-free vial, 10 count, NDC 00409-1559-10
  • Marcaine solution for injection, Pfizer, 0.25%, 30 mL preservative-free vial, 10 count, NDC 00409-1559-30
  • Marcaine solution for injection, Pfizer, 0.25%, 50 mL multiple dose vial, 1 count, NDC 00409-1587-50
  • Marcaine solution for injection, Pfizer, 0.5%, 10 mL preservative-free vial, 10 count, NDC 00409-1560-10
  • Marcaine solution for injection, Pfizer, 0.5%, 30 mL preservative-free vial, 10 count, NDC 00409-1560-29
  • Marcaine solution for injection, Pfizer, 0.5%, 50 mL multiple dose vial, 1 count, NDC 00409-1610-50
  • Marcaine solution for injection, Pfizer, 0.75%, 10 mL preservative-free vial, 10 count, NDC 00409-1582-10
  • Marcaine solution for injection, Pfizer, 0.75%, 30 mL preservative-free vial, 10 count, NDC 00409-1582-29
  • Sensorcaine solution for injection, Fresenius Kabi, 0.5%, 50 mL multiple dose vial, 25 count, NDC 63323-0467-57
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.25%, 10 mL preservative-free vial, 25 count, NDC 63323-0464-17
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.25%, 30 mL preservative-free vial, 25 count, NDC 63323-0464-37
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.5%, 30 mL preservative-free vial, 25 count, NDC 63323-0466-37
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.75%, 30 mL preservative-free vial, 25 count, NDC 63323-0472-37
  • Bupivacaine solution for injection, Eugia US, 0.25%, 10 mL preservative-free vial, 25 count, NDC 55150-0167-10
  • Bupivacaine solution for injection, Eugia US, 0.25%, 30 mL preservative-free vial, 25 count, NDC 55150-0168-30
  • Bupivacaine solution for injection, Eugia US, 0.25%, 50 mL vial, 25 count, NDC 55150-0249-50
  • Bupivacaine solution for injection, Eugia US, 0.5%, 30 mL preservative-free vial, 25 count, NDC 55150-0170-30
  • Bupivacaine solution for injection, Eugia US, 0.5%, 50 mL vial, 25 count, NDC 55150-0250-50
  • Bupivacaine solution for injection, Eugia US, 0.75%, 10 mL preservative-free vial, 25 count, NDC 55150-0171-10
  • Bupivacaine solution for injection, Eugia US, 0.75%, 30 mL preservative-free vial, 25 count, NDC 55150-0172-30
  • Bupivacaine solution for injection, Hikma, 0.25%, 10 mL preservative-free vial, 10 count, NDC 00143-9330-10
  • Bupivacaine solution for injection, Hikma, 0.25%, 30 mL preservative-free vial, 10 count, NDC 00143-9333-10
  • Bupivacaine solution for injection, Hikma, 0.25%, 50 mL vial, 10 count, NDC 00143-9328-10
  • Bupivacaine solution for injection, Hikma, 0.5%, 10 mL preservative-free vial, 10 count, NDC 00143-9331-10
  • Bupivacaine solution for injection, Hikma, 0.5%, 30 mL preservative-free vial, 10 count, NDC 00143-9334-10
  • Bupivacaine solution for injection, Hikma, 0.5%, 50 mL vial, 10 count, NDC 00143-9329-10
  • Bupivacaine solution for injection, Hikma, 0.75%, 10 mL preservative-free vial, 10 count, NDC 00143-9332-10
  • Bupivacaine solution for injection, Hikma, 0.75%, 30 mL preservative-free vial, 10 count, NDC 00143-9335-10
  • Bupivacaine solution for injection, Pfizer, 0.25%, 10 mL preservative-free vial, 25 count, NDC 00409-1159-01
  • Bupivacaine solution for injection, Pfizer, 0.25%, 30 mL glass ampule, 25 count, NDC 00409-1158-01 - discontinued
  • Bupivacaine solution for injection, Pfizer, 0.25%, 30 mL preservative-free vial, 25 count, NDC 00409-1159-02
  • Bupivacaine solution for injection, Pfizer, 0.25%, 50 mL multiple dose vial, 25 count, NDC 00409-1160-01
  • Bupivacaine solution for injection, Pfizer, 0.5%, 30 mL preservative-free vial, 25 count, NDC 00409-1162-02
  • Bupivacaine solution for injection, Pfizer, 0.5%, 50 mL multiple dose vial, 25 count, NDC 00409-1163-01
  • Bupivacaine solution for injection, Pfizer, 0.75%, 10 mL preservative-free vial, 25 count, NDC 00409-1165-01
  • Bupivacaine solution for injection, Pfizer, 0.75%, 30 mL preservative-free vial, 25 count, NDC 00409-1165-02
  • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-02 - discontinued
  • Bupivacaine injection, Baxter, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 36000-0092-10 - discontinued
  • Bupivacaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-3613-01

Reason for the Shortage

• • Eugia has bupivacaine on back order due to shortage of active ingredient.
  • Baxter discontinued 0.75% bupivacaine in 8.25% dextrose 2 mL ampules in early-2023.
  • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.
  • Hikma launched bupivacaine in November 2021.
  • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5% bupivacaine 30 mL glass ampules in December 2017.

Available Products

• • Sensorcaine solution for injection, Fresenius Kabi, 0.25%, 50 mL multiple dose vial, 25 count, NDC 63323-0465-57
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.5%, 10 mL preservative-free vial, 25 count, NDC 63323-0466-17
  • Sensorcaine-MPF solution for injection, Fresenius Kabi, 0.75%, 10 mL preservative-free vial, 25 count, NDC 63323-0472-17
  • Bupivacaine solution for injection, Eugia US, 0.5%, 10 mL preservative-free vial, 25 count, NDC 55150-0169-10
  • Bupivacaine solution for injection, Pfizer, 0.5%, 10 mL preservative-free vial, 25 count, NDC 00409-1162-01
  • Marcaine injection, Pfizer, 0.75% in 8.25% dextrose, 15 mg/2 mL ampule, 10 count, NDC 00409-1761-10
  • Bupivacaine solution for injection, Areva, 0.25%, 10 mL ampule, 10 count, NDC 59923-0719-10
  • Bupivacaine solution for injection, Areva, 0.25%, 5 mL ampule, 10 count, NDC 59923-0717-05
  • Bupivacaine solution for injection, Areva, 0.5%, 10 mL ampule, 10 count, NDC 59923-0720-10
  • Bupivacaine solution for injection, Areva, 0.5%, 5 mL ampule, 10 count, NDC 59923-0718-05

• • Areva is temporarily importing 0.25% bupivacaine and 0.5% bupivacaine 5 mL and 10 mL ampules. FDA is allowing temporary importation of product from Italy manufactured by Areva's supplier, Fisiopharma. Details on how to obtain product and differences between the US and Italian labeling can be found at: https://www.fda.gov/files/drugs/published/BupivacaineDHCPLet033121.pdf.
  • Eugia has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of July 2023 for the 10 mL vials and June 2023 for the 30 mL vials. The 0.25% bupivacaine 50 mL vials are on back order and the company cannot estimate a release date. The 0.5% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2023. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2023. The 0.75% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of June 2023. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company cannot estimate a release date.
  • Fresenius Kabi has 0.25% Sensorcaine 10 mL preservative-free vials on back order and the company cannot estimate a release date. The 0.25% Sensorcaine 30 mL preservative-free vials are on back order and the company estimates a release date of late-June 2023. The 0.5% Sensorcaine 30 mL preservative-free vials are on back order and the company estimates a release date of mid-July 2023. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-July 2023. The 0.75% Sensorcaine 30 mL preservative-free vials are on back order and the company estimates a release date of early-June 2023.
  • Hikma has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company cannot estimate a release date. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of late-June 2023. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company cannot estimate a release date. The 0.5% bupivacaine 50 mL vials are on allocation. The 0.75% bupivacaine 10 mL preservative-free vials are on back order and the company cannot estimate a release date. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of late-July to early-August 2023.
  • Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of July 2023 for the 10 mL vials and June 2023 for the 30 mL vials. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2023. The 0.5% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of August 2023. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2023. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of July 2023 for the 10 mL vials and August 2023 for the 30 mL vials. The 7.5 mg/mL bupivacaine in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of August 2023.
  • Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of August 2023 for the 10 mL vials and March 2024 for the 30 mL vials. The 0.25% Marcaine 50 mL vials are on back order and the company estimates a release date of September 2023. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of June 2023. The 0.5% Marcaine 50 mL vials are on back order and the company estimates a release date of June 2023. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of June 2023 for the 10 mL vials and September 2023 for the 30 mL vials.

• • Bupivacaine and lidocaine are amide-type local anesthetics commonly used in clinical practice. The following table compares their pharmacodynamic and pharmacokinetic properties. Key differences between the products are onset of action, duration of action, and dose. In general, bupivacaine is a longer-acting local anesthetic, while lidocaine has a more rapid onset, but shorter duration of action.[1-2]

  Table 1. Table. Comparison of Bupivacaine and lidocaine for Local Anesthesia1-6

  Property	Bupivacaine	Lidocaine
  * Duration of effect is prolonged by use of local anesthetics in combination with epinephrine, although mangitude of effect is not well-defined for all routes.
  Onset of Action	Infiltration: 2-10 min Epidural: 4-7 min Spinal: 1-15 min	Not well-defined for anesthetic use as a single agent. In general local analgesia 1 to 3 min Spinal and Epidural rapid onset
  Duration of action: As a single agent	Infiltration: 2-8 h Nerve block, minor: 3-6 h Epidural: 3-9 h Spinal: 1.5-3.5 h	Infiltration: 0.5-2 h Nerve block, minor: 1-2 h Epidural: 100 min Spinal: 0.5-2 h
  Duration of action: Combined with epinephrine*	Infiltration: 3-4 h Nerve block, minor: 4-7 h	Infiltration: 2 h Nerve block, minor: 2-3 h
  Maximum Dose	Single injections up to 175 mg without epinephrine or 225 mg with epinephrine; may repeat up to once every 3 hours. Maximum dosage: 400 mg/24 hours.	Maximum: 4.5 mg/kg/dose not to exceed 300 mg without epinephrine or 7mg/kg/dose not to exceed 500 mg with epinephrine; do not repeat within 2 hours. Maximum dose for spinal anesthesia is 100 mg.
  Protein binding	82%-96%	60%-80%
  Volume of distribution	~2.5 L/kg	1.5 + 0.6 L/kg
  Half-life, terminal	Adults: 1.5-5 h Neonates: 8.1 h	Adults: 1.5-2 h Premature infants: 3.2 h
  Metabolism	Undergoes N-dealkylation in the liver.	Extensive hepatic metabolism (90%) with active metabolites.
  Elimination	Excreted in urine as metabolites and 5% as unchanged drug.	Excreted in urine as metabolites (90%) and unchanged drug (<10%).

  
  

• 1. Berde CB, Strichartz GR. Local anesthetics. In: Miller RD, ed. Miller's Anesthesia. 8th ed. Philadelphia, PA: Elsevier Saunders;2015:1028-1054.e4.
  2. Drasner K. Local anesthetics. In: Miller RD, Pardo MC, ed. Basics of Anesthesia. 6th ed. Philadelphia, PA: Elsevier Saunders;2011:130-142.
  3. Drugdex system. Micromedex 2.0 [database online]. http://www.micromedexsolutions.com. Updated March 13, 2018. Greenwood Village, CO: Truven Health Analytics; Accessed March 13, 2018.
  4. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc; 2018.
  5. Bupivacaine hydrochloride and epinephrine injection, solution [package insert]. Lake Forest, IL: Hospira Inc; 2017.
  6. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2018.