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Sagent Pharmaceuticals is voluntarily recalling 10 lots of methylprednisolone sodium succinate for injection 40 mg, 125 mg, and 1 g vials. Impurity results for 2 of these lots were above specification. The specific impurity has not been identified, and has not resulted in any reports of adverse patient events. The high impurity levels have the potential to decrease effectiveness of the product.
Affected products include the following:
- Methylprednisolone sodium succinate for injection, 40 mg (NDC 25021-0807-05) – Lot AJM601, AJM701, AJM702
- Methylprednisolone sodium succinate for injection, 125 mg (NDC 25021-0808-10) – Lot AJN601, AJN701, AJN702
- Methylprednisolone sodium succinate for injection, 1 g (NDC 25021-0810-30) – Lot AJP701, AJP702, AJP601, AJP703
Sagent Pharmaceuticals is notifying customers of the recall, and providing return instructions by fax, email, FedEx, and/or certified mail. Customers who have further distributed the product should contact the recipients and notify them of the recall. Consumers should report any adverse reactions experienced from this product to their provider and the FDA’s MedWatch Adverse Event Reporting program. Customers may contact Sagent with questions regarding this recall by phone at (866) 625-1618.
Additional Information:
- MedWatch Safety Alert – March 6, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm599663 - Sagent Pharmaceuticals, Inc. press release – March 5, 2018
www.fda.gov/Safety/Recalls/ucm599581.htm