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Epinephrine Injection

[24 June 2016]

Products Affected - Description

Epinephrine injection, Amphastar
0.1 mg/mL 10 mL syringe, package of 10 (NDC 76329-3316-01)
 
Epinephrine injection, BPI Labs
1 mg/mL, 2 mL containing 1 mL sulfite-free and preservative-free ampule, 10 count (NDC 54288-0103-10)
 
Epinephrine injection, Hospira
0.1 mg/mL, 10 mL Abboject18 gauge glass syringe, package of 10 (NDC 00409-4901-18)

Reason for the Shortage

  • American Regent discontinued both epinephrine presentations in early 2015.
  • Amphastar states the shortage is due to increased demand.
  • BPI Labs received FDA approval for epinephrine injection in 2014 and the company launched product in February 2015.
  • Hospira has epinephrine syringes on shortage due to manufacturing delays.

Available Products

Adrenalin injection, Par Sterile Products
1 mg/mL, 1 mL contains sulfite preservative-free vial, 25 count (NDC 42023-0159-25)
1 mg/mL, 30 mL multiple dose vial, 1 count (NDC 42023-0168-01)
 
Epinephrine injection, Amphastar
1 mg/mL, 30 mL vial, 1 count (NDC 76329-9061-00) 
 
Epinephrine injection, Hospira
0.1 mg/mL, 10 mL 20 gauge LifeShield syringe, 10 count (NDC 00409-4921-34)
1 mg/mL, 1 mL preservative-free (contains sulfite) ampule, 25 count (NDC 00409-7241-01)

Estimated Resupply Dates

  • Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on intermittent back order and the company is releasing product regularly.
  • Hospira has epinephrine 0.1 mg/mL 10 mL 18 gauge Abboject syringes on back order and the company cannot estimate a release date.
  • BPI Labs has epinephrine 1 mg/mL 1 mL ampules available with an expiration date of September 2016. The company estimates a release date of July 2016 for product with better dating.

Implications for Patient Care

  • Epinephrine products from Amphastar and Hospira are not FDA approved. BPI Lab's epinephrine injection is labeled to increase mean arterial blood pressure in patients with hypotension associated with septic shock. Par's Adrenalin is labeled for emergency treatment of anaphylaxis and induction and maintenance of mydriasis during intraocular surgery.
  • Adrenalin injection vials from Par Sterile Products are considered to be preservative-free, but contain 1 mg/mL sodium metabisulfite. Hospira's epinephrine ampules are considered to be preservative-free, but contain 0.9 mg/mL sodium metabisulfite.
  • BPI Lab's epinephrine injection is preservative free and sulfite-free.

Related Shortages

Updated

June 24 and 1, May 10, April 25, 12 and 6, February 8, 2016; December 23 and 10, November 4, September 18, August 24 and 6, July 23, 13 and 2, June 16 and 11, April 22 and 15, March 19, February 13, 2015; December 15, November 21 and 20, October 8, August 26 and 6, June 11, April 30 and 3, March 7, February 19, January 16, 2014; December 13, October 16 and 15, September 16, August 13, June 19, May 30 and 9, April 26 and 8, March 21 and 18, February 25 and 6, January 23 and 14, 2013; December 26, 18 and 3, November 30 and 7, October 26, September 25, August 17 and 1, July 25, June 28 and 15, May 18 and 2, March 27 and 9, February 23 and 8, January 25, 17 and 13, 2012; November 15, September 14, August 9, July 15, June 13, May 4 and 3, 2011, University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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