Steroid Injection Recalled Due to Impurity Results

No adverse events have been reported from using the affected product lots
No adverse events have been reported from using the affected product lots

Sagent announced a voluntary recall of 10 lots of Methylprednisolone Sodium Succinate for Injection in 40mg, 125mg, and 1g strengths. The recall was initiated due to the discovery of high out of specification impurity results during routine quality testing of stability samples for 2 lots. 

While the impurity has not yet been identified, an elevated presence can potentially decrease the efficacy of the product in patients. No adverse events have been reported from using the affected product lots. 

Methylprednisolone Sodium Succinate for Injection, an anti-inflammatory glucocorticoid, is used for various conditions such as allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, miscellaneous (trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy), neoplastic diseases, nervous system, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders. 

The recalled products are supplied in 5mL, 10mL, and 30mL glass tubular vials and were distributed between April 2017 and February 2018. The full list of affected Lot #s is as follows:

Methylprednisolone Sodium Succinate for Injection 40mg

  • AJM601
  • AJM701
  • AJM702

Methylprednisolone Sodium Succinate for Injection 125mg

  • AJN601
  • AJN701
  • AJN702

Methylprednisolone Sodium Succinate for Injection 40mg

  • AJP701
  • AJP702
  • AJP601
  • AJP703

Customers in possession of the affected products should quarantine, discontinue distribution, and arrange for return. 

Related Articles

For more information call (866) 625-1618 or visit SagentPharma.com.