Accord Healthcare, Inc. initiated a recall of Bivalirudin for Injection 250 mg on July 3, 2023. The FDA classified this action as a Class II recall.
The recalled product is Bivalirudin for Injection 250 mg, supplied in 10 single-dose vials, Rx Only, NDC 16729-275-67. It was manufactured for Accord Healthcare, Inc. of Durham, NC, and manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India.
The stated reason for the recall is the presence of particulate matter, identified as fiber. This was documented under FDA recall record D-0918-2023.
According to the FDA record, the status of this recall is listed as terminated. The recall classification and reason are reported here as stated in the FDA record, without additional interpretation.
Bivalirudin is an approved compound. This recall action pertains specifically to the identified lot and product described above.
For more background on bivalirudin, readers can consult the compound overview.