Class II · ModerateRecall completed
Metformin Hydrochloride Extended Release 750 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
Where it was soldProduct was distributed to one customer 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) impurity above the acceptable intake level (per manufacturer)
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 | 70518-2480-00 |
Show the full FDA record
| Full product label | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00 |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Product was distributed to one customer in PA. |
| Quantity | 79/30 count blister cards |
| Recall initiated | 2020-10-11 |
| Report date | 2020-11-04 |
| Recall completed | 2021-02-24 |
| Recall number | D-0050-2021 |
| 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.