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
Reported: September 29, 2021 Initiated: August 27, 2021 #D-0820-2021
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 28658 cartons
- Distribution
- Nationwide.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 28658 cartons.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0820-2021.
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