Sagent Pharmaceuticals Inc. began a voluntary recall of 10 lots of an anti-inflammatory steroid for injection after discovering impurity in samples for two lots.
The injection, methylprednisolone sodium succinate, is sold in 40-milligram, 125-milligram, and 1-gram vials and is manufactured by India's Gland Pharma Ltd. and distributed by Sagent.
The medicine, which Pfizer Inc. sells under the brand name Solu-Medrol, is used to treat different conditions such as arthritis, blood disorders, severe allergic reactions and immune system disorders among others.
The Illinois-based drugmaker said the impurity has not yet been identified and, to date, it is not aware of any adverse patient events resulting from the use of the subject product lots.
A high level of impurity can potentially lower the medicine's effectiveness in patients, the company said in its press release.
Sagent said the recalled lot numbers were distributed to hospitals, wholesalers, and distributors nationwide from April 2017 through February 2018. The recall is being extended to the user level in the distribution chain which includes patients, wholesalers, hospitals/laboratories, healthcare professionals, pharmacies and retailers.
