Sagent Pharmaceuticals, Inc. today 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 below. These products were manufactured by Gland Pharma Ltd. and
distributed by Sagent Pharmaceuticals. Sagent has initiated this
voluntary recall of Methylprednisolone Sodium Succinate for Injection,
USP to the user level due to the discovery of high out of specification
impurity results detected during routine quality testing of stability
samples for two lots. This impurity has not yet been identified.
An elevated impurity has the potential to decrease effectiveness of the
product in patients. To date, Sagent is not aware of any adverse patient
events resulting from the use of the subject product lots.
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