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Class II · ModerateRecall completed

Metformin Hydrochloride Extended Release

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

Does this affect you?
Check your lot numberLot: 04DE1902, 11DE1908 Exp. 06/30/2021
Where it was soldFL
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

  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 bydirect rx
Brand nameMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forDirect Rx Dawsonville, GA 30534
NDC72189-064-90
Show the full FDA record
Full product labelMetformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Recalling firmDirect Rx
DistributionFL
Quantity88 bottles
Recall initiated2020-10-12
Report date2020-11-11
Recall completed2021-09-22
Recall numberD-0058-2021
ClassificationClass II
FDA statusTerminated
Origin on fileDawsonville GA 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.