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Class II · ModerateRecall completed

Metformin Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberM008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
Where it was soldProduct was distributed to 17 wholesalers who further distributed the product to 85 locations.
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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byViona Pharmaceuticals Inc
Brand nameMETFORMIN HYDROCHLORIDE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forVIONA PHARMACEUTICALS INC
NDC72578-036-01
Show the full FDA record
Full product labelMetformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Recalling firmVIONA PHARMACEUTICALS INC
DistributionProduct was distributed to 17 wholesalers who further distributed the product to 85 locations.
Quantity23,8416/100 count bottles
Recall initiated2021-12-27
Report date2022-02-02
Recall completed2023-09-20
Recall numberD-0392-2022
ClassificationClass II
FDA statusTerminated
Origin on fileCranford NJ United States

Related

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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.