Class II · ModerateRecall completed
Metformin 750 mg Extended Release NDC # 70518-2920-00
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # J0511265-021121, exp. date 02/28/2022 J0499451-122220, exp. date 01/31/2022 J0496563-120820, exp. date 12/31/2021 J0495111-120120, exp. date 12/31/2021
Where it was soldProduct was distributed to one direct account in PA.
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: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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 | 70518-2920-00 |
Show the full FDA record
| Full product label | Metformin 750 mg Extended Release NDC # 70518-2920-00 |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Product was distributed to one direct account in PA. |
| Quantity | 56 Blister Cards |
| Recall initiated | 2021-12-30 |
| Report date | 2022-01-19 |
| Recall completed | 2022-03-28 |
| Recall number | D-0366-2022 |
| 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.