Class II · ModerateRecall completed
Fosphenytoin Sodium Injection
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # AP160016; Exp. 05/18
Where it was soldMS, NC, OH, TX, UT
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of Particulate Matter
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Amneal Biosciences, Bridgewater, NJ 08807 |
| NDC | 70121-1390-7 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Amneal Pharmaceuticals LLC |
| Distribution | MS, NC, OH, TX, UT |
| Quantity | 14,000 vials |
| Recall initiated | 2017-08-31 |
| Report date | 2017-11-22 |
| Recall completed | 2019-09-10 |
| Recall number | D-0076-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Glasgow KY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.