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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 numberXP9004, exp 12/2020
Where it was soldNationwide
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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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 byMarksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India foreign manufacturer
Brand nameMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forTime-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA
NDC49483-623-01
Show the full FDA record
Full product labelTime-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Recalling firmMarksans Pharma Limited
DistributionNationwide
Quantity11279 bottles
Recall initiated2020-06-05
Report date2020-07-01
Recall completed2023-09-07
Recall numberD-1356-2020
ClassificationClass II
FDA statusTerminated
Origin on fileVasco Da Gama N/A India

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.