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    • 08 MAR 18
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    Alert: Sagent recalls injected methylprednisolone sodium succinate

    Alert: Sagent recalls injected methylprednisolone sodium succinate

    MAR 08, 2018

    U.S. Food and Drug Administration

    Comprehensive Ophthalmology, Uveitis

    Sagent Pharmaceuticals announced a voluntary nationwide recall of 10 lots of methylprednisolone sodium succinate (40mg, 125mg and 1g) due to high impurity levels detected during routine quality testing. The products were manufactured by Gland Pharma Ltd.

    Methylprednisolone sodium succinate is an anti-inflammatory glucocorticoid indicated for a number of conditions, including various ophthalmic diseases. The product is supplied in 5 ml, 10 ml, and 30 ml glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide from April 2017 through February 2018. A detailed list of products and lots is provided in the table below.







    Product

    Lot Numbers

    Expiration Date

    NDC Number

    Distribution Dates

    Methylprednisolone Sodium Succinate for Injection, USP, 40mg

    AJM601
    AJM701
    AJM702

    Jul-2018
    Dec-2018
    Dec-2018

    25021-807-05
    25021-807-05
    25021-807-05

    Apr – Aug 2017
    Aug – Nov 2017
    Nov 2017 – Feb 2018

    Methylprednisolone Sodium Succinate for Injection, USP, 125mg

    AJN601
    AJN701
    AJN702

    Jun-2018
    Dec-2018
    Dec-2018

    25021-808-10
    25021-808-10
    25021-808-10

    Apr – Oct 2017
    Aug 2017 – Jan 2018
    Dec 2017 – Feb 2018

    Methylprednisolone Sodium Succinate for Injection, USP, 1g

    AJP701
    AJP702
    AJP601
    AJP703

    Dec-2018
    Dec-2018
    Jul-2018
    Aug-2019

    25021-810-30
    25021-810-30
    25021-810-30
    25021-810-30

    Sep – Dec 2017
    Dec 2017 – Feb 2018
    Apr – Sep 2017
    Jan – Feb 2018

    Customers are being notified of the recall by fax, email, FedEx and/or certified mail, with instructions for returning all recalled product. Sagent is urging all customers to examine their inventory and to quarantine, discontinue distribution of and return the recalled lot.

    The form needed to document this information, as well as other information regarding this recall, is available at www.Sagentpharma.com. Customers with questions about returning unused product should call 1-866-625-1618 during business hours (M-F, 8am-7pm CST).  

    Physicians and patients can report adverse reactions or quality issues to the FDA through the MedWatch Adverse Event Reporting site or by mail or fax (1-800-FDA-0178).

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