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Recalls of syringes, AXP bags, generic drugs
From the January ACP Hospitalist, copyright © 2009 by the American College of Physicians
By Jessica Berthold
Recalls and warnings
A recall of ThermoGenesis Corp’s disposable Auto Xpress stem-cell processing bags, lot numbers 08B13 and 08C04. Particulates from the stopcock in the bagset may be released into the sterile, non-pyrogenic fluid path. The introduction of a particulate into the body can cause serious injury to a patient being transfused with cord blood that has been stored in these units, the manufacturer said.
An expanded recall of Ethex Corp. generic drugs that may contain oversized tablets with too much active ingredient. The recall now affects dextroamphetamine sulfate (10 mg); isosorbide mononitrate, extended release (30 mg, 60 mg); morphine sulfate, extended release (15 mg); morphine sulfate, immediate release (15 mg, 30 mg); and propafenone HCl (150 mg, 225 mg, 300 mg). Specific lot information is online.
A recall of one lot of Covidien’s ReliOn hypodermic insulin syringes because of possible mislabeling that may cause patients to get up to 2.5 times the intended dose and lead to hypoglycemia and/or death. The recall applies to lot number 813900 of the product labeled “ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin.” Some syringes labeled for use with U-40 insulin were mixed with these, packaged together, and sold at Wal-Mart and Sam’s Club stores from Aug. 1 to Oct. 8.
A recall of 1 oz tubes of 10% benzoyl peroxide acne cream marketed as “DG Maximum Strength Acne Medicated Gel,” “Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication” and “Equate: Medicated Acne Gel,” which are sold at Dollar General, Kroger and Wal-Mart, respectively. Some samples of these products contained Burkholderia Cepacia, which can cause infections for people with cuts, scrapes, rashes or other skin conditions; or for those with weakened or suppressed immune systems.
A boxed warning for efalizumab (Raptiva) about the risks of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections. Patients should have received all age-appropriate vaccinations before starting the drug and should be educated about the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia and thrombocytopenia.
Approvals
Rufinamide (Banzel) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome. Side effects may include headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Patients should be monitored for depression, suicidal thoughts or behavior, and unusual changes in mood or behavior.
Fesoterodine fumarate (Toviaz) for overactive bladder. The 4 mg and 8 mg extended release tablets are available by prescription. Common side effects are dry mouth, constipation, dry eyes and trouble emptying the bladder. The drug isn’t recommended in doses above 4 mg in patients with reduced kidney function, or in patients taking medications like ketoconazole that block the metabolism of the drug. It also shouldn’t be used in patients with severe liver impairment, those who suffer from urinary or gastric retention or those with uncontrolled, narrow-angle glaucoma.
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