Voluntary Antibiotic Recall Initiated
Three lots of ertapenem, (Invanz) 1g (0803930, 0803940, and 0803950), a Merck antibiotic that is indicated for the treatment of patients with moderate to severe infections, were recalled because of two incidents of broken glass found in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. All lots have an expiration date of October 2008, and no other lots were affected by this recall. Medical questions about the recall can be directed to Merck’s national service center at 800–672–6372.
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The full prescribing information for omalizumab (Xolair) injection has been revised to include a new Boxed Warning and updated Warnings, Precautions, and Adverse Reactions sections to address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication [more].
All children in the US ages 12 to 23 months should receive the hepatitis A vaccine as a two-dose regimen [more].
Revisions have been made to the Contraindications, Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections of the prescribing information for Roche’s ceftriaxone (Rocephin) for injection [more].
Shelhigh, Inc. has agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with Food and Drug Administration (FDA) standards [more].