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.
Free Daily News
- Hospital addresses barriers to patient rest, recovery
- Study: Psilocybin therapy reduces depression in frontline clinicians
- Exclusive articles preview OR Business Management Conference sessions
- Study: Surgeries improve survival in young BRCA-positive breast cancer patients
- Study: Advanced recovery room care could reduce long-term postoperative mortality
- FDA designates Class 1 recalls for balloon catheters, radiographic markers
- Orthopedic surgery in 2025: Embracing innovation, preserving autonomy
- Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance
- Anthem’s anesthesia time limit policy, reversal sparks new legislation
- Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion