FDA-Drug2021-09-29Class II

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

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide.
Affected count
28658 cartons
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2021

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