Bulletin

Amiodarone Hydrochloride Injection

15 October 2009

Products Affected - Description

Amiodarone 50 mg/mL injection
3 mL vial, package of 10 (NDC 00548-3380-00), Amphastar - discontinued
3 mL vial, package of 25, Novaplus label (NDC 63323-0616-13), APP - discontinued
3 mL vial, package of 10 (NDC 55390-0057-10), Bedford
3 mL vial, package of 10 (NDC 00143-9875-10), Westward

9 mL vial, package of 10 (NDC 10019-0133-04), Baxter
9 mL vial, package of 1 (NDC 55390-0105-01), Bedford

18 mL vial, package of 1 (NDC 10019-0133-02), Baxter

18 mL vial, package of 1 (NDC 67457-0153-18), Bioniche

18 mL vial, package of 1 (NDC 55390-0057-01), Bedford

Reason for the Shortage

Amphastar will not provide a reason for the discontinuation.
Baxter states the shortage is due to a vendor delay.
Bioniche cannot state a reason for the shortage.
Teva cannot provide a reason for the shortage.
APP Pharmaceuticals (formerly Abraxis Pharmaceutical Products) and Bedford state the shortage is due to increased demand.
GeneraMedix and Apotex discontinued their amiodarone injection some time ago.

Estimated Resupply Dates

Amphastar discontinued their product on January 25, 2008.
Bedford has all presentations on back order. The company cannot estimate a release date.
Baxter has available the 3 mL vial in packages of 10 (NDC10019-0133-01). Other presentations of amiodarone injection are on back order and the company cannot estimate a release date.
APP has amiodarone injection available in 3 mL vials (NDC 63323-0616-03) and 9 mL vials (NDC 63323-0616-09). The company has discontinued the 3 mL Novaplus vials.
Bioniche has available their 3 mL vials (NDC 67457-0153-03) and 9 mL vials (NDC 67457-0153-09). The 18 mL vials are on back order with an estimated release date of late-October, 2009.
Hospira has 3 mL ampules (NDC 00409-4348-35) and 3 mL Novaplus ampules (NDC 00409-4348-49) available.
Sagent has 3 mL syringes (NDC 25021-0302-73) available.
Teva has 9 mL vials (NDC 00703-1335-01) available.
Westward has their amiodarone injection on back order and the company estimates a release date of November, 2009.

Related Shortages

Updated

October 15, 2009; September 3, 2009; July 30, 2009; July 1, 2009; June 1, 2009; May 11, 2009; April 17, 2009; February 27, 2009; February 11, 2009; December 15, 2008; December 2, 2008; November 17, 2008; October 20, 2008; October 7, 2008; September 5, 2008; September 3, 2008; July 28, 2008; July 22, 2008; June 18, 2008; May 16, 2008; April 30, 2008; April 3, 2008; March 31, 2008; March 13, 2008; March 10, 2008; February 7, 2008; January 28, 2008, University of Utah, Drug Information Service. Copyright 2009, University of Utah, Drug Information Service.

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