• Organic Particulates Lead to Recall for B.Braun Antibiotic

    The US Food and Drug Administration (FDA) has announced that B. Braun Medical (B.Braun) is voluntarily initiating a recall of one lot of its injectable antibiotic Cefepime after "visible organic particulate matter" was observed in a reserve sample unit. The drug, a combination of 1g Cefepime for Injection USP and Dextrose Injection USP, was first approved in May 2010 and comes in both 1g and 2g (approved in 2012) formulations.  It is indicated to "reduce the dev...
  • Recalls by Hospira Continue to Mount as Company Finds Hair, Glass, Steel and Brass

    Sterile drug manufacturer Hospira is once again initiating a voluntary recall under the supervision of the US Food and Drug Administration-at least the third major recall in recent months due to particulate contamination. Background The company has been subject to a number of recalls-and a Warning Letter-in recent months. In August 2013, Hospira issued a recall of one lot of Aminosyn , an amino acid solution administered intravenously, after a customer reported findi...
  • Breaking Device: Too-High Device at Risk of Breakdown, Says Company

    Amongst the long list of reasons for medical device product recalls-manufacturing mishaps, faulty designs, programming errors-few seem as odd as the reason behind a recall initiated on 27 September 2013: The Colorado Rockies exist. Well, maybe not the Rockies, per se, but the rationale behind Carfusion's Class 1 recall for its Avea Ventilator product is pretty much the same. In the voluntary recall notice posted on the US Food and Drug Administration's (FDA) website, t...
  • FDA Announces Bevy of Sterility-Related Recalls

    The US Food and Drug Administration's (FDA) MedWatch staff had an unusually busy 6-8 September 2013 weekend, announcing the recall of products from three companies due to serious problems that could potentially affect patient safety. The Return of Recalls for McNeil One of the three companies is McNeil Consumer Healthcare, a Johnson & Johnson subsidiary that has conducted a number of high-profile recalls of many widely available products in recent years, including...
  • Fallout from Deficient Contract Testing Facility Continues, Prompting Fourth Company to Issue Recall

    Fallout from deficient findings at a contract testing laboratory used by dozens of pharmaceutical compounders continues to upend the compounding industry, with yet another company initiating a nationwide recall after it said it was unable to confirm whether its products are indeed sterile. Background In August 2013, the US Food and Drug Administration issued a  statement  that Loveland, CO-based Front Range Laboratories, Inc. had been observed to be using defi...
  • Human Hair Found in IV Solution Prompts Hospira Recall

    Biopharmaceutical manufacturer Hospira has found itself in something of a hairy situation-literally. In a 30 August 2013 announcement, the company said it was voluntarily initiating a voluntary recall of one lot of Aminosyn, an amino acid solution administered intravenously, after a customer reported finding an "unknown foreign particle" in the injection port of the product. Hopefully Flake-Free… That "foreign particle," Hospira explained , was human hair-a dec...
  • Feature ArticlesFeature Articles

    What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions

    Due to multi-million-dollar (and sometimes billion-dollar) settlements, the vast majority of headlines regarding off-label promotion cases in recent years have involved drugs. Although less prominent, the US Food and Drug Administration (FDA) has steadily continued to act against medical device manufacturers for the same conduct, mostly in the form of Warning Letters. Between 1 May 2012, and 30 April 2013, FDA's Center for Devices and Radiological Health issued 24 Warning...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

    A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication. Background FDA regulates pharmaceutical compounders differently than traditional m...
  • Rare Letter to Compounding Pharmacy Shows FDA Demanding Recall of Potentially Unsterile Products

    Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls-a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one-they rarely get a glimpse into how that recall is ordered. Background On 18 May 2013, FDA issued two notices regar...
  • UK Recall Notice Shows Even the Simplest Devices Capable of Causing Patient Harm

    Medical devices are often complicated products-something reflected in a great deal of recall notices around the world. Sometimes a mechanical defect can imperil the safety of a multimillion-dollar piece of machinery; other times a simple software glitch can have unintended consequences. And then there's a recall notice issued by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on 24 July 2013 involving ostensibly the simplest of all devices: a walking s...
  • Industry Slams Device Recall Guidance, Highlighting Perceived Flaws

    The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of clarification, major revisions or outright removal. Background Recall regulations stipulate that any action taken by a manufacturer to correct a defect or performance failure that could pose a risk to public health may be defined by the agency as a recall, even if the action is condu...