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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 numberLots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22; c) A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22; d) B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22
Where it was soldAK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
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 byPD-Rx Pharmaceuticals, Inc.
Brand nameMETFORMIN HYDROCHLORIDE EXTENDED RELEASE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forPD-Rx Pharmaceuticals, Inc.
NDC72789-009-30
Show the full FDA record
Full product labelmetformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Recalling firmPD-Rx Pharmaceuticals, Inc.
DistributionAK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Quantity1683 bottles
Recall initiated2020-10-06
Report date2020-11-11
Recall completed2021-10-22
Recall numberD-0059-2021
ClassificationClass II
FDA statusTerminated
Origin on fileOklahoma City OK 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.