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
D-0610-2018
Product summary
- Event
- Event 79610
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,584 vials
- Official record key
drug-enforcement:D-0610-2018
Official wording
Reason: Presence of particulate matter
Code information: Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
Distribution pattern: U.S.A Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter