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Shortage of Fentanyl Injection products continues

October 19th, 2011

The availability of Fentanyl Injection products continues to be limited. The American Society of Health-System Pharmacists (ASHP) lists the following affected products:

Products Affected - Description

Hospira

Fentanyl Injection 50 mcg/mL,
10 mL ampules (NDC 00409-9093-36) - discontinued
2 mL Carpuject syringe (NDC 00409-1276-32)
2 mL ampule (NDC 00409-9093-32)
20 mL ampule (NDC 00409-9093-38)
2 mL vial (NDC 00409-9094-22)
5 mL vial (NDC 00409-9094-25)
20 mL vial (NDC 00409-9094-31)
50 mL vial (NDC 00409-9094-61)

West-Ward (formerly Baxter products)

Fentanyl Injection 50 mcg/mL,
10 mL ampule (NDC 10019-0034-73) - discontinued
30 mL single-dose vial (NDC 10019-0 036-82) - discontinued
2 mL vial (NDC 10019-0037-27)
5 mL vial (NDC 10019-0037-30)
20 mL vial (NDC 10019-0037-25)
50 mL vial (NDC 10019-0037-83)

Hospira notes that they are experiencing manufacturing issues with some presentations of ampoules and vials. Product availability from Hospira and West-Ward, which acquired Baxter's fentanyl injection products in May 2011, are as follows:

  • Hospira has available Fentanyl Inj USP CII (0.05mg/ml) 5ml) ampoule (NDC 00409-9093-35) and Fentanyl Iinj USP CII (0.05mg/ml) 10 ml FTV (NDC 00409-9094-28). The 2 ml Carpuject syringes (NDC 0409-1276-32) are on back order with an estimated release date of late-October 2011. All other presentations are on back order with an estimated release date as noted:
    NDC# Description Delivery System Exp. Release Date
      0409-9093-38 Fentanyl Inj USP CII
    (0.05mg/ml) 20ml
    Ampoule Mid-December 2011
      0409-9094-22 Fentanyl Inj USP CII
    (0.05mg/ml) 2ml
    FTV Mid-January 2012
      0409-9094-25 Fentanyl Inj USP CII
    (0.05mg/ml) 5ml
    FTV Mid-January 2012
      0409-9094-61 Fentanyl Inj USP CII
    (0.05mg/ml) 50ml
    FTV Mid-December 2011
      0409-9094-31 Fentanyl Inj USP CII
    (0.05mg/ml) 20ml
    FTV Mid-December 2011
      0409-9094-31 Fentanyl Inj USP CII
    (0.05mg/ml) 20ml
    Ampoule Late April 2012
  • West-Ward has available Fentanyl 50 mcg/mL 2 mL (NDC 10019-0038-67), 5 mL (NDC 10019-0033-72 and 20 mL (NDC 10019-0035-74) ampules. The 2 mL, 5 mL, 20 mL and 50 mL vials are on back order. The company estimates a release date of mid- to late-October 2011.

Southern Anesthesia and Surgical (SAS) is expecting to receive limited quantities of Fentanyl from Hospira and West-Ward in various sizes during this interruption.

SAS will be allocating product based on availability and receipt of a 222 form. In order to reserve a place in line for product as it becomes available, members are encouraged to send in a 222 form requesting Fentanyl.

SAS will be contacting members as their orders become available to ship. It may be necessary to send in a revised 222 form based on product size availability.

To check status of your submitted 222 order please call 1-888-222-3722

SAS also reminds OMSs that if they use the company's new e-222 program, Schedule II orders may be placed online without the need to mail the form.

To learn more about e-222 online ordering visit us at www.southernanesthesia.com or call 1-800-624-5926.

AAOMS will continue to monitor and keep the membership informed about the shortage of Fentanyl Injectable and other drug products used in the OMS office.