FDA recall D-0076-2018
Amneal Pharmaceuticals LLC · Class II · drug
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Reason for recall
Presence of Particulate Matter
Distribution
MS, NC, OH, TX, UT
Key facts
- Status
- Terminated
- Initiation date
- 2017-08-31
- Report date
- 2017-11-22
- Termination date
- 2019-09-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Glasgow, KY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0076-2018