Class II · ModerateRecall completed
Ranitidine 150 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
Where it was soldFL, GA
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
| Distributed by / for | Direct Rx Dawsonville, GA 30534 |
| NDC | 61919-339-60 |
Show the full FDA record
| Full product label | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 |
| Recalling firm | Direct Rx |
| Distribution | FL, GA |
| Quantity | a) 54 bottles; b) 26 bottles |
| Recall initiated | 2020-01-15 |
| Report date | 2020-10-14 |
| Recall completed | 2020-12-07 |
| Recall number | D-0016-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Dawsonville GA 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.