March 22, 2018
Sagent Pharmaceuticals Inc. is recalling 205,370 single-dose vials of methylprednisolone sodium succinate for injection, USP, 40 mg (NDC 25021-807-05), after discovering high out-of-specification impurity results during routine quality testing.
According to the March 21, 2018, US Food and Drug Administration (FDA) Enforcement Report, the following 3 lots are included in the recall: AJM601 (Exp. 7/18), AJM701 (Exp. 12/18), and AJM702 (Exp. 12/18). Vials from the lots were distributed across the United States.
Sagent Pharmaceuticals voluntarily initiated the recall March 5, 2018. On March 12, 2018, the FDA designated it Class II, indicating that use of affected vials could cause a temporary health problem.
Methylprednisolone sodium succinate for injection is a prescription anti-inflammatory glucocorticoid used to treat numerous conditions, including allergic states, endocrine disorders, gastrointestinal diseases, respiratory diseases, and rheumatic disorders.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here