Class II · ModerateActive recall
Glenmark Ranitidine Tablets USP 300 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Where it was soldNatiowide
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 byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ foreign manufacturer
| Distributed by / for | Glenmark Pharmaceuticals Inc., USA Mahwah, NJ |
| NDC | 68462-249-30 |
Show the full FDA record
| Full product label | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | Natiowide |
| Quantity | 98,988 bottles |
| Recall initiated | 2019-12-17 |
| Report date | 2020-01-15 |
| Recall completed | — |
| Recall number | D-0641-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Mahwah 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.