• Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems

    Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at least the second related to the particulate contamination, according to previous reports. Background In October 2010, Sandoz initiated a similar recall of its methotrexate vials, noting the "presence of glass particles" in the product. "Due to particle size, there is the po...
  • Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

    • 16 May 2013
    Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and large-scale medical device problems. Pharmaceuticals Pharmaceuticals as a category is made up of two types of products: Drugs manufactured under traditional conditions, such as in a large-scale manufacturing facility, and drugs that are compounded, often on a one-off bas...
  • Plastic Packaging Leads to more than a Dozen Major Device Recalls for Cardinal Health

    A little piece of plastic is causing big headaches for Cardinal Health after its Medical Products and Services Division announced more than a dozen Class 1 recalls because of the potential for a device's plastic packaging to get stuck in its filter, obstructing airflow to a patient being operated on. The recalls affect at least 13 device kits manufactured by the company, the majority of which seem to be contained within or otherwise related to Cardinal's Presource PBDS ...
  • Compounding Pharmacy Recalls all Products after FDA Finds Microbial Contamination in Vials

    The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination. Background Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without havi...
  • Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month

    • 15 April 2013
    Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary recall for all its blood glucose meter devices, citing the same core defect that led to last month's recall of a similar product manufactured by Johnson & Johnson. Background On 25 March 2013, Lifescan, a subsidiary of Johnson and Johnson, issued a recall of nearly 2 million...
  • Imaging Device has Potential to Display Other Patients' Images, Says Company in Recall Notice

    When undergoing a medical imaging procedure, patients expect some measure of clarity. If for instance, a patient goes in for an angiography, they expect their doctor to be able to use the image to diagnose any cardiac problems that might be present or other renal problems. But as one recent recall shows, patients could be none the wiser if a medical device accidentally displays the wrong information from an imaging procedure. The device in question is Toshiba's Infinix-I...
  • Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

    A steady drumbeat of recalls from compounding pharmacies has struck a note for the third time in approximately a week, with Massachusetts-based Pallimed Compounding Pharmacy issuing a notice indicating that all sterile products manufactured at the facility should be recalled and not used after an inspection by the US Food and Drug Administration (FDA) indicated deficiencies. In a statement, the company said it had not been made aware that any compounded product made by i...
  • Second Compounding Pharmacy Recalls all Products After Sterility Concerns Raised

    For the second time in a single week, a US-based compounding pharmacy has announced the recall of all of its compounded products, again due to contamination affecting supposedly sterile products. The company, Georgia-based Clinical Specialties, issued a voluntary recall notice on 20 March 2013 indicating that all products manufactured by the company were at risk due to "lack of sterility assurance." Similar problems have plagued the industry in recent months, starting ...
  • Another Compounding Pharmacy in Spotlight as it Recalls all Products Due to Contamination

    • 18 March 2013
    Another US-based pharmaceutical compounding pharmacy has recalled all of its products after it said they could potentially be contaminated with mold. A similar recall was initiated in 2012 by the New England Compounding Pharmacy (NECC), whose products have been linked to a massive outbreak of fungal meningitis that has killed dozens and made ill hundreds of other patients. When FDA investigators raided the plant in October 2012, they found vials of product at the facilit...
  • Indian Regulators Finalize Recall System Requirements

    Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and biological drugs, bringing the country much more closely in line with the recall standards of most established regulatory authorities. The draft guideline , released in late October, was available for public comment for 15 days. A side-by-side analysis of the draft and final guide...
  • Hospira Initiates Class I Recall for Touchscreen, Software Issues

    • 30 October 2012
    Medical device manufacturer Hospira has issued a voluntary Class I recall in the US for its Symbiq Infusion system after being made aware that the device's LCD touch screens were occasionally unresponsive, causing errors, treatment delays, incorrect treatment or treatment interruptions. The class of devices is used to deliver exact amounts of medication to patients, and Hospira markets it as a method to achieve compliance with good clinical practice guidelines. In ...
  • Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised

    UK regulators with the Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug alert to healthcare practitioners warning them of a recall involving Sanofi Pasteur MSD's typhoid vaccine, Typhim Vi. In its 8 October warning, MHRA said while the vaccine remained safe, concerns had been raised about the product's effectiveness against typhoid, and the agency urged all patients who recently traveled abroad and remained "unwell" to seek medical attentio...