The Recall Desk
SevereFDA (Drugs)·D-0820-2021·Announced 2021-09-29

Fulvestrant Injection Recall: Lack of Sterility Assurance

Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. A lack of sterility assurance for an injectable prescription drug presents a significant risk of serious adverse health consequences, including infection, sepsis, and other complications. Although no specific illnesses or injuries are reported in the source text, the nature of the defect—loss of sterility control in a parenteral product—and the agency's Class II classification justify a Severe rating.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Fulvestrant Injection 250 mg/5 mL (50 mg/mL) for intramuscular use due to lack of assurance of sterility. The recalled product is supplied in cartons containing 2 single-dose pre-filled syringes, NDC 68462-317-32, and was distributed nationwide.

The recall affects 28,658 cartons across 20 lots with expiration dates ranging from April 2022 through January 2023. The affected lot numbers are: 30200014 (Exp. 04/30/2022), 30200015 (Exp. 05/31/2022), 30200016 (Exp. 05/31/2022), 30200036 (Exp. 09/30/2022), 30200038 (Exp. 09/30/2022), 30200039 (Exp. 09/30/2022), 30200040 (Exp. 09/30/2022), 30210001 (Exp. 12/31/2022), 30210002 (Exp. 12/31/2022), 30210003 (Exp. 01/31/2023), 30210004 (Exp. 01/31/2023), 30210005 (Exp. 01/31/2023), 30210006 (Exp. 01/31/2023), 30210014 (Exp. 02/28/2023), 30210022 (Exp. 02/28/2023), 30210028 (Exp. 02/28/2023), 30210029 (Exp. 02/28/2023), 30210030 (Exp. 02/28/2023), and 30210031 (Exp. 02/28/2023).

Patients and healthcare providers in possession of affected product should discontinue use. Consult with a healthcare provider regarding appropriate treatment options. Report adverse reactions to the FDA MedWatch program or contact Glenmark Pharmaceuticals Inc., USA for additional information.

The recalled product

Product
FULVESTRANT (FULVESTRANT)
Brand
FULVESTRANT
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Injectable / Sterile Preparation
Hazard
  • lack-of-sterility
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Lots: 30200014 Exp. 04/30/2022
  • 30200015 Exp. 05/31/2022
  • 30200016 Exp. 05/31/2022
  • 30200036 Exp. 09/30/2022
  • 30200038 Exp. 09/30/2022
  • 30200039 Exp. 09/30/2022
  • 30200040 Exp. 09/30/2022
  • 30210001 Exp. 12/31/2022
  • 30210002 Exp. 12/31/2022
  • 30210003 Exp. 01/31/2023
  • 30210004 Exp. 01/31/2023
  • 30210005 Exp. 01/31/2023
  • 30210006 Exp. 01/31/2023
  • 30210014 Exp. 02/28/2023
  • 30210022 Exp. 02/28/2023
  • 30210028 Exp. 02/28/2023
  • 30210029 Exp. 02/28/2023
  • 30210030 Exp. 02/28/2023
  • 30210031 Exp. 02/28/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · FULVESTRANT

Same category