Recall: D-0820-2021
Class II - Potentially Harmful
Class IIClassification
2021-08-27Initiated
TerminatedStatus
Glenmark Pharmaceuticals Inc.,Firm
Product
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
Reason
Lack of Assurance of Sterility
Distribution
Nationwide.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.