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Class II · ModerateActive recall

Metformin

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

Does this affect you?
Check your lot numbera) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
Where it was soldUS Nationwide
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 byGranules India Limited, Hyderabad - 500-081, India foreign manufacturer
Brand nameMETFORMIN
Generic nameMETFORMIN ER 500 MG
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forGranules Pharmaceutical Inc., Chantilly, VA
NDC70010-492-01
Show the full FDA record
Full product labelMetformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India
Recalling firmGranules Pharmaceuticals Inc
DistributionUS Nationwide
Quantitya) 476,073 bottles; b) 2,100 bottles
Recall initiated2020-07-03
Report date2020-07-22
Recall completed—
Recall numberD-1386-2020
ClassificationClass II
FDA statusOngoing
Origin on fileChantilly VA 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.