Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

Recall Number: D-0820-2021

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Terminated

Report Date: 20210929

Initiation Date: 20210827

Termination Date: 20231004

Reason for Recall

Lack of Assurance of Sterility

Product Description

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32