Reported Sep 29, 2021 · Terminated
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- 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
- Lot codes and dates
- Lots
30200014 Exp. 04/30/202230200015 Exp. 05/31/202230200015 Exp. 05/31/202230200016 Exp. 05/31/202230200036 Exp. 09/30/202230200038 Exp. 09/30/202230200039 Exp. 09/30/202230200040 Exp. 09/30/202230210001 Exp. 12/31/202230210002 Exp. 12/31/202230210003 Exp. 01/31/202330210004 Exp. 01/31/202330210005 Exp. 01/31/202330210006 Exp. 01/31/202330210014 Exp. 02/28/202330210022 Exp. 02/28/202330210028 Exp. 02/28/202330210029 Exp. 02/28/202330210030 Exp. 02/28/202330210031 Exp. 02/28/2023
- Lots
- Amount recalled
- 28658 cartons
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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