Class II · ModerateRecall completed
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackag
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020
Where it was soldProduct was distributed to two facilities in CA and NY.
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 Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
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 | RemedyRepack Inc. |
| NDC | 65162-0253-10 |
Show the full FDA record
| Full product label | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00 |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Product was distributed to two facilities in CA and NY. |
| Quantity | 4,486 tablets |
| Recall initiated | 2019-12-11 |
| Report date | 2020-01-29 |
| Recall completed | 2020-07-23 |
| Recall number | D-0798-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Indiana PA 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.