Recalls: Propofol, ventilators, infusion sets, acetaminophen

A voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B, due to the presence of elevated endotoxin levels in some vials with these lot numbers.

A Class I recall of BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P, due to power supply failures on some ventilators. The product was distributed from August 2006 through April 11, 2008. Customers may contact Respironics U.S. Customer Service at 1-877-387-3377.

A voluntary recall of Medtronic's Quick-set infusion sets, used with MiniMed Paradigm insulin pumps, because the sets may not allow the insulin pump to vent air pressure properly. This could result in the device delivering too much or too little insulin and may lead to serious injury or death. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8”; patients should discontinue using “Lot 8” sets. The manufacturer will replace the sets for free.

A voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16-ounce (473 ml) bulk containers, manufactured by Pharmaceutical Associates, Inc. Because the 16 oz container is comparable in size to the packaging of regular strength acetaminophen liquid preparations, dosing errors may occur. Overdose of acetaminophen may result in liver toxicity, kidney damage, and blood disorders.

A voluntary recall of lot #370-9004 of Mallinckrodt Sodium Chromate Cr-51 Injection because routine post-market testing found the product to be subpotent.

A voluntary recall of lot number D50002 of Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein), single-dose pre-filled syringes. A portion of a bulk lot of the syringes, which wasn't meant for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. Manufacturer Wyeth said it performed a medical assessment and concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.

Updated labels for some immunosuppressant drugs used to help prevent rejection of kidney transplants, to reflect an increased risk of opportunistic infections. The required label changes affect sirolimus (Rapamune), cyclosporine (Sandimmune), cyclosporine modified (Neoral), mycophenolate mofetil (Cellcept) and mycophenolic acid (Myfortic).

A review of safety data for insulin glargine (Lantus), due to the recent publication of three studies that suggest an increased risk of cancer in patients with diabetes who have used the drug.

A safety review of arthroscopic shavers in light of reports that pieces of tissue sometimes remain within the shaver, even after cleaning according to the manufacturer's instructions. If retained tissue is discovered, facilities should file a voluntary report with MedWatch, the FDA Safety Information and Adverse Reporting program online.

A lab analysis of electronic cigarette samples found they contain carcinogens and toxic chemicals like diethylene glycol, an ingredient used in antifreeze. Aside from its limited testing, the FDA said it has no way of knowing the levels of nicotine or the amounts or kinds of other chemicals that various brands of electronic cigarettes deliver.

Approvals

The 2009-2010 seasonal influenza vaccine, which will comprise three virus strains that U.S. and international officials believe are likely to cause the most illness during the upcoming flu season: an A/Brisbane/59/2007 (H1N1)-like virus, an A/Brisbane/10/2007 (H3N2)-like virus and a B/Brisbane/60/2008-like virus. It will not protect against the pandemic swine-origin H1N1 influenza.

Blood thinner prasugrel (Effient) to reduce the risk of blood clots in angioplasty patients. The drug's labeling will include a boxed warning that prasugrel can cause significant, sometimes fatal, bleeding. It shouldn't be used in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

Fentanyl buccal soluble film (Onsolis) to help cancer patients manage breakthrough pain. The absorbable film, which sticks to the inside of the cheek, is meant for opioid-tolerant patients age 18 and older who already use opioid pain management continuously. It was approved with a boxed warning against use to manage migraines, dental pain, or postoperative pain; or use by patients who take opioids intermittently or on an as-needed basis. It will only be available through a restricted distribution program.

A one-dose formulation of emergency contraception pill levonorgestrel (Plan B One-Step). The original pill requires two doses. People aged 17 and older will be able to buy Plan B One-Step over the counter; those 16 and under will need a prescription.

Miscellaneous

The FDA is evaluating the interim findings of an ongoing study of asthma drug omalizumab (Xolair) which suggest an increased risk of several adverse cardiovascular and cerebrovascular conditions. The conditions include ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events. The FDA isn't advising patients to stop taking the drug, nor is it recommending changes to prescribing information at this time, but urges providers to be aware of the potential risks.