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    Home > Medical News > Latest Medical News > Customers complained about the loose caps of sterile medicines. Pharmaceutical companies took the initiative to recall

    Customers complained about the loose caps of sterile medicines. Pharmaceutical companies took the initiative to recall

    • Last Update: 2021-04-28
    • Source: Internet
    • Author: User
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    On March 11, the FDA issued a recall announcement, and the US Saijin Pharmaceuticals voluntarily recalled three batches of injection products.


    The recall originated from a customer complaint that indicated the possibility of loosening of the cap seal of the vial, which indicated that the aseptic performance of the product could not be guaranteed.


    Company announcement date: March 11, 2021

    FDA release date: March 11, 2021

    Product Category: Medicine

    Recall reason: lack of sterility guarantee

    Recall company: Saijin Pharmaceutical

    Product description: Phenylephrine Hydrochloride Injection

    Company Announcement

    Company Announcement

    Sagent Pharmaceuticals, Inc.


    Figure: The importance of the cap seal of the vial for sterile preparations-from left to right are incomplete capping, correct capping, and over capping

    Security Risk

    Security Risk

    Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist used to treat clinically significant hypotension, which can be caused by vasodilation under anesthesia.


    Picture: The label of the recalled product

    If the sterile preparations for intravenous injection are in a non-sterile state, they may cause serious systemic infections, which can be life-threatening.


    Recall arrangement

    Recall arrangement

    The product is provided in the form of a 3 mL glass tube vial.


    Picture: Information of the recalled product (product, batch number, expiration date, NDC number, distribution date)

    Saijin Pharmaceuticals is notifying customers via fax, e-mail, FedEx and/or certified mail, including arrangements for returning all recalled products.


    If customers or consumers have any questions about returning unused products, they can call the customer service center of Saijin Pharmaceutical; medical personnel who have medical questions about this product can contact the Medical Affairs Department of Saijin Pharmaceutical.


    For adverse reactions or quality problems encountered using this product, you can report to the FDA's MedWatch Adverse Event Program online, regular mail or fax.


    The recall was carried out with the knowledge of the US FDA.


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