FDA recall D-0610-2018
Amneal Pharmaceuticals · Class II · drug
Product
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Reason for recall
Presence of particulate matter
Distribution
U.S.A Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-12-15
- Report date
- 2018-04-04
- Termination date
- 2020-08-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brookhaven, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2018