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3/4/2020

Bacitracin for Injection

Products Affected - Description

    • Baciim intramuscular powder for solution for injection, X-Gen, 5000 units, vial, 10 count, NDC 39822-0277-02 - discontinued
    • Bacitracin intramuscular powder for solution for injection, Fresenius Kabi, 5000 units, vial, 10 count, NDC 63323-0329-31 - discontinued
    • Bacitracin intramuscular powder for solution for injection, Fresenius Kabi, 5000 units, vial, NDC 63323-0329-30 - discontinued
    • Bacitracin intramuscular powder for solution for injection, Pfizer, 5000 units, vial, 10 count, NDC 00009-0233-03 - discontinued
    • Bacitracin intramuscular powder for solution for injection, Pfizer, 5000 units, vial, NDC 00009-0233-01 - discontinued
    • Bacitracin intramuscular powder for solution for injection, Xellia Pharmaceuticals, 5000 units, vial, 10 count, NDC 70594-0026-02 - discontinued

Reason for the Shortage

    • FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market

Available Products

    • There are no presentations available

Estimated Resupply Dates

    • FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market. All products will be discontinued.

Implications for Patient Care

    • Bacitracin for intramuscular injection is labeled for treatment of pneumonia and empyema in infants. The product is most frequently used for intraoperative irrigation of surgical wounds. FDA published a report in April 2019 that describes the evidence for use of bacitracin irrigations, as well as information about adverse reactions. The report can be found at the following link: https://www.fda.gov/media/123641/download
    • The guidelines for antimicrobial prophylaxis in surgery developed by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Surgical Infection Society, and the Society for Healthcare Epidemiology of America do not support the use of antimicrobial irrigation solutions due to lack of evidence demonstrating additional benefits over use of intravenous antimicrobial prophylaxis alone.[1]

References

    1. Bratzler, D.W., et al., Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm, 2013. 70(3): p. 195-283.

Updated

Updated March 4, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 3, 2020 by Rachael Freeman, PharmD, BCPS. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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