echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > A large number of injections have been recalled!

    A large number of injections have been recalled!

    • Last Update: 2020-09-06
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    The preservatives listed on the label are parabens and parabens and do not contain the preservative benzoyl alcohol, and the preservatives present in the product do not match the label.
    August 18, the FDA's website announced that a U.S. drug company had voluntarily recalled sodium heparin intravenous bag products nationwide because of improper use of preservatives.
    the reason for the voluntary recall of 10 batches of sodium heparin from SCA Pharmaceuticals in Windsor, USA.
    recalled to hospital/user levels because heparin sodium products contain the unstated preservative benzoyl alcohol.
    preservatives are parabens and parabens listed on their labels.
    , the preservatives present in the product do not match the label.
    SCA Pharmaceuticals discovered the label problem during an investigation into low product content bias.
    heparin as an anticoagulant and is packed in 500 mL or 1000 mL intravenous bags.
    this affected heparin sodium batch includes: phenyl methanol adverse reaction benzo alcohol is prohibited for children and pregnant or lactating women.
    The use of benzoyl alcohol as a preservative at the time, regardless of its content, could lead to fatal reactions and severe adverse reactions, including "breathing syndrome", in premature and low-birth-weight infants in neonatal intensive care units.
    other adverse reactions include gradual deterioration of the nervous system, seizures, skull bleeding, blood abnormalities, ruptured skin, liver and kidney failure, low blood pressure, slower-than-expected heart rhythms, and loss of adequate cerebral blood flow to maintain awareness.
    babies born prematurely and low birth weight may be more likely to have these reactions because they have lower metabolism.
    addition, benzo alcohol present in the mother's serum may penetrate into breast milk and may be absorbed oral by nursing infants.
    , it is recommended to inject heparin-free sodium heparin when heparin treatment is required during pregnancy.
    SCA Pharmaceuticals said it had not received any complaints or adverse event reports related to the recall so far.
    , however, SCA Pharmaceuticals voluntarily recalls the batches listed here out of caution.
    announcement that the heparin sodium product is distributed to hospitals nationwide in the United States in the form of hospital distribution.
    can identify sodium heparin by checking the product name, concentration, and lot number on the bag.
    SCA Pharmaceuticals is notifying its customers and is arranging for the return of all recalled products.
    hospital should stop using the product and return it to SCA.
    adverse reactions or quality issues encountered in using this product can be reported to the FDA's MedWatch Adverse Event Reporting Program online, by regular mail or fax.
    recall was made with the FDA's knowledge.
    's outsourcing facility for the deployment of the drug SCA Pharmaceuticals, which is itself positioned as an "industry-leading 503B organization" for the deployment of drugs, is designed to address the clinical needs of certain individual patients listed earlier in order to address the drug on the market.
    The FDA allows the provision of drugs for the clinical needs of these individual patients, which is Section 503A (Pharmacy Preparations) and 503B (Outsourcing Site Preparations) of the Federal Food, Drug, and Cosmetic Act.
    In the U.S., hospital pharmacies and social pharmacies that supply drugs, or entrust outsourced sites with drugs that do not require approval, that is, exempt from approval, but the FDA retains the power to regulate sites that inspect non-compliant sites, send warning letters and take regulatory action.
    the end of 2012, the United States suffered the worst drug-poisoning incident in recent history, in which hundreds of people in 20 states contracted fungal infections caused by the use of disinsisting drugs, resulting in more than 60 deaths.
    Ref.: (FDA) sCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationalwide Recall of Heparin Sodium Compounded Products Due to Martin Preservative (Benzyl Alcohol)
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.