FDA recall D-1351-2022

Product

Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2022-07-15

Report date

2022-08-24

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2022