Approved Hospital Formulary
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Approved Hospital Formulary
03/04/20 jr FYI - Bacitracin for injection - no longer manufactured
March 4, 2020
From: "Jerry Robinson Pharm.D." <jerry.robinson@hhsys.org>
To: "Pharmacists" <allpharm@hhsys.org>
Sent: Wednesday, March 4, 2020 11:38:50 AM
Subject: FYI - Bacitracin for injection - no longer manufactured
A Pulse page announcement was made this morning as below:
Bacitracin injection (used off-label for irrigation) - no longer available
All manufacturers of bacitracin for injection have withdrawn their products from the market based on FDA ruling. This means bacitracin that has been used off-label for irrigation during surgery cases will no longer be available. Please review current literature when deciding on alternative therapies. Saline irrigation alone may be warranted. This affects Bacitracin IV product only. Bacitracin ointment is not affected.
Background:
Bacitracin for injection was originally discussed by FDA for removal in 1984 due to safety concerns with accidental IV adminstration, nephrotoxicity, and need for repeated IM injections. However, it wasn't until 2019 that it was reexamined and voted to be removed. All manufacturers have voluntarily removed their products from the market. Our quantities should be depleted soon and OR staff may begin questioning us for alternatives.
This drug discontinuation will be presented to Surgery Committee next week for further recommendations on use of irrigation intraoperatively.