• Sandoz Issues Recall After Packaging Errors Found

    Novartis AG subsidiary Sandoz announced on Wednesday, 6 June the initiation of a recall for ten lots of its oral contraceptive Intravole (levonorgestrel) after consumers notified the company of a packaging mix-up. Sandoz said the packaging error resulted in pills containing placebos being placed incorrectly within the blister packs, opening the possibility of consumers taking the oral contraceptives at the incorrect time. The blister packs ordinarily contain the placebo ...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • Pfizer Recalls 653,000 Bottles of Advil After CGMP Deficiencies Cause 'Strong Odor'

    • 21 May 2012
    New York-based pharmaceutical manufacturer Pfizer has recalled more than 653,000 bottles of its Advil Liqui-Gels pain-reliever after becoming aware of a "strong odor" in the product, reports Dow Jones Business Wire . The products, composed of eight lots manufactured at an Argentina-based facility operated by contract manufacturing organization (CMO) Catalent Argentina S.A.I.C., were recalled from retail-distribution centers in March, according to a US Food and Drug Admi...
  • Report: 'Dramatic' Increase in Q1 Medical Device Recalls

    A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls. Medical device recalls increased 160% from Q4 2011 through Q1 2012 while the number of recalled units increased 508%, writes Mike Rozembajgier of the recall tracking company ExpertRECALL. The number of recalls was the most since 2010. While the increase was "dramatic," it also...
  • Brazil: New Risk Mitigation Regulation for Devices

    A new regulation ( RDC n o.23 ) published on 9 April 9 2012, requires marketing authorization holders to undertake a series of actions to reduce the risk associated by adverse events related to devices that are marketed in Brazil.  The required actions may involve the effective and timely recall of the product and the need to disseminate public warning messages.  The company must also report to ANVISA the actions it has undertaken, including the assistanc...
  • FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

    A report issued by the US Food and Drug Administration (FDA) is faulting a New York-based company for failing to test its sterile wipe products even after recalling hundreds of millions of products due to bacterial contamination, reports The Bellingham Herald. The company, Professional Disposables Incorporated, initiated a recall in September 2011 involving 300 million alcohol pads which were supposed to be sterile but were instead contaminated with Bacillus cerus. Tha...
  • Group: Medical Device, Pharmaceutical Recalls Down Significantly

    A recent study shows that both medical device and pharmaceutical recalls were down significantly over the fourth quarter of 2011, decreasing 63% and 35% respectively. The study , conducted by Stericycle ExpertRECALL , found that medical devices only experienced 106 recalls in the fourth quarter of 2011. This was down 63% from the previous quarter and 57% from the previous year. Recalls primarily affected Class II medical devices, accounting for 93% of all device types ...
  • Implementation of Medical Device Recall Authority Sought by FDA

    The US Food and Drug Administration (FDA) announced on 10 February that it is seeking to implement its medical device recall authority under § 518(e) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Chapter 21, Section 810 of the Code of Federal Regulations (CFR). Section 518(e) allows FDA to order manufacturers to cease distribution of a device and notify health professionals if FDA finds a "reasonable probability that the device intended for human...
  • Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

    Swiss pharmaceutical company Novartis Consumer Health Inc. recalled four products yesterday, citing quality concerns that could expose consumers to " foreign tablets, caplets, or capsules ," as well as broken and chipped pills. The product recall affects four popular Novartis-made drugs: Excedrin, NoDoz, Bufferin and GasX. The US Food and Drug Administration's (FDA) statement noted that consumers could be exposed to dangerous doses, unintended ingredients, allergic reac...