Class II · ModerateRecall completed
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberall lots within expiry.
Where it was soldNationwide
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
CGMP Deviations: Presence of NDMA impurity detected in product.
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 byNovitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520
| Distributed by / for | Novitium Pharma LLC |
| NDC | 70954-002-10 |
Show the full FDA record
| Full product label | Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10 |
| Recalling firm | Novitium Pharma LLC |
| Distribution | Nationwide |
| Quantity | 12312 bottles |
| Recall initiated | 2019-10-25 |
| Report date | 2019-11-20 |
| Recall completed | 2021-03-17 |
| Recall number | D-0312-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | East Windsor NJ 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.