A look at some recent recalls in the US of prescription medicines and medical devices

A look at recent recalls of medical products

PRESCRIPTION DRUGS

—The Medicines Company, March 17, Cleviprex (a calcium channel blocker to rapidly reduce high blood pressure). Stainless steel particles in some vials.

—Baxter International, May 17, genetically engineered Hylenex, a pediatric rehydration solution. Small glass particles in some vials.

—Hospira, May 27, expanded recall of injected anesthetic propofol to the consumer level. Stainless steel particles in some containers.

—Blacksmiths Brands, May 28, four versions of PediaCare for coughs and colds. Recalled as a precaution because they were made at Johnson & Johnson’s now-closed Fort Washington, Pa., manufacturing plant.

—Claris LifeSciences, June 1, injected antibiotics ciprofloxacin and metronidazole, and injected nausea treatment Ondansetron. Floating matter/possible contamination in I.V. bags. This also affected Pfizer and a number of other companies that distribute Claris products to U.S. hospitals.

—Procter & Gamble, June 24, 4-Hour Decongestant Nasal Spray. Product may not match expiration dates on the package.

—Bristol-Myers Squibb, July 14, Coumadin (blood thinner) 1 mm tablet blister packs. Over time the level of active ingredient (Coumadin) could decrease because some of the tablets may not meet specifications for isopropanol, an ingredient that maintains the Coumadin. This could increase risk of blood clots, heart attack or stroke.

DEVICES

—LifeScan (part of Johnson & Johnson), February 24, OneTouch SureStep Test Strips for blood glucose levels. May provide falsely low results, which could lead to diabetes patients injecting too little insulin, raising risk of coma, death or long-term complications such as organ damage.

—Teleflex Medical, March 12 (update to a recall reported February 25), all lots of custom I.V. tubing sets and accessories, and some catheters. Pinholes in product packages could compromise sterility and lead to serious infection or death.

—Covidien, April 23, multiple types of tracheostomy tubes. Air leaks in the pressure cuff could trigger a sudden decrease in oxygen in the blood or sudden increase in carbon dioxide in the blood, potentially causing serious injury or death.

—Teleflex Medical, May 6, worldwide recall of condenser humidifiers that warm and humidify air for patients on breathing machines. A faulty connector could cause the breathing tube to disconnect, causing serious injury or death if medical personnel do not respond promptly.

—Defibtech, June 3, battery packs used on Lifeline and ReviveR semiautomatic external defibrillators. Error may occur during charging that cancels the charge. The release states: “Defibtech determined the need for this recall after learning of four reports from end users of this malfunction during patient use.” That would seem to indicate someone might have been harmed.