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 #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
Where it was soldU.S.A Nationwide
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
Made byMade in India foreign manufacturer
| Distributed by / for | Amneal Biosciences, Bridgewater, NJ 08807 |
| NDC | 70121-1390-1 |
Show the full FDA record
| Full product label | Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1 |
| Recalling firm | Amneal Pharmaceuticals |
| Distribution | U.S.A Nationwide |
| Quantity | 12,584 vials |
| Recall initiated | 2017-12-15 |
| Report date | 2018-04-04 |
| Recall completed | 2020-08-03 |
| Recall number | D-0610-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Brookhaven NY 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.