Recalls, warnings, label changes
A warning that some Carpuject prefilled cartridges manufactured by Hospira, Inc. may be overfilled by at least twice the expected amount. Because clinicians can visually identify the presence of an overfilled cartridge, the FDA is recommending visual inspections at this time rather than a product recall. A recall of the affected products would result in an immediate shortage.
A warning about a counterfeit version of Adderall, 30-mg tablets, being sold online. Adderall is classified as a controlled substance and is currently in short supply. The counterfeit version contains tramadol and acetaminophen in place of Adderall's four active ingredients.
A recall of Curlin infusion administration sets because of the potential that they contain a reverse pump segment, which could send the flow of fluid or medicines in the opposite direction than intended, potentially causing blood loss, under-delivery of medication or fluid, or a delay in therapy.
A recall of Baxa Corporation's Abacus total parenteral nutrition calculation software due to a potential for dosing errors. Errors have been reported by users ordering salt-based parenteral nutrition ingredients on an ion-based ordering template, a practice which the software is not designed to support.
New contraindications and monitoring recommendations for fingolimod (Gilenya) due to the risk of cardiovascular effects. It is contraindicated in patients with certain preexisting or recent heart conditions or stroke, and those taking certain antiarrhythmic medications. The FDA recommends six hours of cardiovascular monitoring after the first dose for every patient and more extended monitoring in patients who are at higher risk for or who may not tolerate bradycardia.
A recall of certain lots of the generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) due to a consumer report that white placebo tablets were mistakenly in the ninth row of the 13-row blister card, rather than in the correct position in the 13th and final row. Although the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.
The Percutaneous Surgical Set, the first surgical instrument set that can be assembled and disassembled inside the body during surgery. It is intended to be used during minimally invasive laparoscopic abdominal surgery and was approved under the FDA's de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device.
The first generic versions of clopidogrel bisulfate (Plavix). Manufacturers Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharma- ceuticals have approval to make 300-mg formulations. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg.
Pertuzumab (Perjeta) to treat patients with HER2-positive metastatic breast cancer. Intended for patients who have not received prior treatment with an anti-HER2 therapy or chemotherapy, this new humanized monoclonal antibody is combined in treatment with trastuzumab and docetaxel. Production issues could potentially affect long-term supply of the drug, but the manufacturer has committed to taking steps to resolve the issues.
Following the publication of a study that found azithromycin is associated with increased cardiovascular mortality, the FDA announced it is in the process of updating risk information on the labels of macrolide antibiotics.