FDA: Recall of methylprednisolone sodium succinate for injection
Editor's Note
The Food and Drug Administration (FDA) on March 6 announced the recall by Sagent Pharmaceuticals (Schaumburg, Illinois) of 10 lots of methylprednisolone sodium succinate for injection, USP, 40 mg, 125 mg, and 1 g.
The recall was initiated because of the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. The impurity has not yet been identified.
The products were manufactured by Gland Pharma Ltd (Ameerpet, Hyderabad, India) and distributed by Sagent Pharmaceuticals.
Posted 03/06/2018] AUDIENCE: Pharmacy, Risk Manager ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed in the recall notice. These products were manufactured by Gland Pharma Ltd.
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