Recalls and warnings
A recall of several American Regent injectable products (bacteriostatic sodium chloride, concentrated sodium chloride, sodium thiosulfate, and potassium phosphates) because of visible particulates consistent with glass delamination, which could result in damage to blood vessels in the lung, localized swelling and granuloma formation.
A recall of certain lots of AccuProbe culture identification tests for Group B Streptococcus, Mycobacterium tuberculosis and Mycobacterium avium because the kits may contain tube components that are partially empty or empty of solution. Possible false-negative results may occur.
A recall of Roche ACCU-CHEK FlexLink Plus infusion sets due to potential for under-delivery of insulin due to a cannula which may become kinked or bent.
A recall of one lot (FI0510058-A) of citalopram 10-mg tablets (100-count bottle) and finasteride 5-mg tablets (90-count bottle) due to the possibility that incorrect labels may have been placed on the bottles by a third-party manufacturer. Bottles labeled as citalopram may contain finasteride.
A recall of five lots of irinotecan hydrochloride injection, after customer reports of a particulate in one lot. The particulate was found to be a fungal microbial contaminant and lots produced before and after the affected one have been recalled as a precaution.
An expansion of approval for the Zostavax vaccine, for the prevention of shingles in individuals 50 to 59 years of age. The vaccine was already approved for use in individuals 60 years of age and older.
Gadobutrol (Gadavist), a new gadolinium-based contrast agent (GBCA), for use in patients undergoing MRI of the central nervous system. Gadobutrol is more concentrated than the other GBCAs and should be administered at half the volume. All GBCAs carry a boxed warning about the risk of nephrogenic systemic fibrosis. Headache and nausea were the most common adverse reactions in trials of gadobutrol.
The Excimer Laser Assisted Non-Occlusive Anastamosis (ELANA) surgical kit, which allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery. Consisting of a small platinum ring and a hand piece connected to a surgical laser and suction tubing, the device allows neurosurgeons to create a bypass without shutting off blood flow. It was approved as a humanitarian use device, designed to treat a condition in fewer than 4,000 people in the U.S. each year.
The Cepheid Xpert C. difficile/Epi assay, a test designed to rapidly detect the toxin B gene associated with Clostridium difficile infection. The test determines if C. difficile is in a patient's stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain.
The test is intended for use as an aid in diagnosis. The detection of the 027/NAP1/B1 strain is for epidemiological purposes only and should not be used to determine or monitor treatment.
The FDA currently reviewing the safety of lenalidomide (Revlimid) after clinical trials conducted inside and outside the United States found that patients treated with the drug may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. At this time, the agency is not recommending delay, modification or restriction for patients being treated according to the FDA-approved indications, but any new recommendations will be communicated after the review is complete.
The FDA is alerting health care professionals and the public about the association of methemoglobinemia, a serious and potentially fatal adverse effect, with benzocaine sprays, gels and liquids. Benzocaine gels and liquids are sold over-the-counter under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase. The sprays are used during medical procedures to numb the mucous membranes of the mouth and throat and are marketed under different brand names such as Hurricaine, Cetacaine, Exactacain, and Topex. The FDA is continuing to evaluate the safety of benzocaine and will update the public when it has additional information.