Alert: Sagent recalls injected methylprednisolone sodium succinate

alert-sagent-recalls-injected-methylprednisolone-sodium-succinate.jpg

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).

https://www.aao.org/headline/alert-sagent-recalls-injected-methylprednisolone-s

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