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
D-0076-2018
Product summary
- Event
- Event 78035
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,000 vials
- Official record key
drug-enforcement:D-0076-2018
Official wording
Reason: Presence of Particulate Matter
Code information: Lot # AP160016; Exp. 05/18
Distribution pattern: MS, NC, OH, TX, UT
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter