• December 6, 2013

    Our Quality Confirmed

    Jubilant HollisterStier LLC is comprised of two business models, HollisterStier Allergy and JHS Contract Manufacturing & Operations (CMO). While we do share a facility, HS Allergy focuses strictly on allergenic products and processes. Last week we completed our annual ISO 13485 surveillance audit to support the quality systems used for our skin test devices. We are pleased to report there were zero observations made by the auditor. These results verify that the allergy Quality systems are robust, and ensure consistently high quality products for our customers. Even with these positive results, our efforts to enhance our systems will continue.

    Click here to read more.

  • October 28, 2013

    2013 ACAAI Annual Scientific Meeting

    The 2013 ACAAI Annual Scientific Meeting, New Frontiers in Allergy and Immunology: From Bench to Clinic, will be held November 7-11 in Baltimore, Maryland. We hope you are able to come take part in the educational sessions for allergy professionals, enjoy the social events, and explore the exhibit booths showcasing products especially suited to your practice. HollisterStier Allergy will be among the exhibitors at booth 815. Please stop by if you are attending the meeting.

  • July 10, 2013

    Recall Letter from our President

    Dear Valued Clients:

    We have voluntarily recalled ABS and NSP made in 2mL, 5mL, and 10mL tube glass vials. These vials use a different manufacturing process than molded glass vials. Our molded glass vials that are used for Sterile Empty Vials and extract product vials have not shown indications of glass delamination.

    Glass delamination is an industry wide problem. Greater emphasis on inspections has resulted in higher sensitivity for detection. Subsequently, there have been a number of product recalls in the pharmaceutical industry over the last few years. Please see the links on our website where we reference some of this information.

    All the ABS and NSP product made in these tube glass vial sizes over the last 3 years are subject to this voluntary recall. It is with patient safety in mind that we are recalling this product. Please bear in mind that the shelf life of these vials is 3 years and through our stability studies, we discovered the glass flakes after 18 months sitting in ambient (room) temperature. Samples of these products that had been stored in 2-8ºC conditions did not show the same delamination. This leads to the belief that the delamination process is accelerated by higher temperature. Therefore, vials that were used in mixing, stored in a refrigerator, and consumed with no less than 18 months dating prior to expiration have a very low probability of delamination.

    It is important to note, despite the possibility of some harmful effects of injecting glass by subcutaneous method, there have been no reported adverse events or market complaints related to this issue in the past 3 years that we can identify.

    As a quality conscious organization, we were glad to have identified this problem through vigilance and strict adherence to industry best practices. The patient’s safety is our first concern and our relationship with our trusted and respected physicians is critical. In an effort to minimize the risk and expediently correct the problem, we are prepared to offer our clients a credit for any returned 2mL, 5mL, and 10mL ABS or NSP diluents. Though it is likely that this product will be on hold for some time in our factory, we have contacted the other manufacturers to ensure you can receive prompt replacement of this product. You should expect to hear from a representative shortly to facilitate your needs.

    We thank you for your understanding and cooperation. You should have received a letter detailing the process for returning product with any lots and invoice dates that may have affected you. In the meantime, please don’t hesitate to contact our office directly if we can be of immediate assistance or answer any additional questions. We look forward to quickly resolving this issue and returning to manufacturing the high quality diluents you expect from HollisterStier.

    If you have questions or would like more immediate information, please feel free to contact me directly. Thank you for your cooperation as we work to make this a quick process with the least disruption to your practice as possible.

    Best regards,

    Kevin Garrity
    PRESIDENT, HOLLISTERSTIER ALLERGY

    To download patient information on our glass delamination recall please visit:www.glassdelaminationrecall.com.

  • July 3, 2013

    Glass Delamination, an industry-wide issue

    At HollisterStier Allergy we conduct ongoing stability studies on our products, and have recently discovered samples of our ABS and NSP stored at room temperature and at the 18 month dating checkpoint showed evidence of glass delamination. In the interest of patient safety, we are voluntarily recalling all of our 2mL, 5mL, and 10mL vials of ABS and NSP. The recall includes all orders over the last three years for these products that were packaged in tube glass vials. Customers who received products included in the recall were sent a letter detailing the product lot numbers and invoice dates, along with detailed instructions for returning those products.

    Glass delamination has been a long-standing problem in the pharmaceutical industry that has recently been gaining visibility at the customer level. An increase in drug recalls linked to the issue over the last few years has the attention of both customers and the FDA, causing them to issue a drug safety statement to the entire industry. The recalls have involved many different manufacturers, with many product types being affected. Fortunately there have been no reports of patients injured as a result of these incidents. The US Pharmacopeial Convention has drafted guidance, “Evaluation of the Inner Surface Durability of Glass Containers,” to set standards for testing for glass delamination. Testing can be preformed on containers in real time stability samples or on vials under accelerated aging temperatures.

    The problem is that delamination is difficult to predict because it can take years for the glass fragments or glass lamellae to be visible. Type 1 glass (USP <660>, EP 3.2.1, ASTM E438) is used for all injectable drug products. It is defined by its level of hydrolytic resistance, but can still have chemical and compositional difference that can be significant. These differences account for a wide range of heats needed for shaping containers. The process used to produce the vials is also a factor, tubular or molded, with molded glass compositions being viewed to have a higher resistance to glass delamination. Glass composition is only one of several risk factors for delamination: storage time, storage temperatures, the chemistry of the drug itself, and sterilization processes also have the potential to increase the risk of delamination.  

    To download patient information on our glass delamination recall please visit:www.glassdelaminationrecall.com.

    To learn more about glass delamination: