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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 numbera) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22
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: detection of 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 Indl. 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
NDC49483-623-09
Show the full FDA record
Full product labelTime-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only 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 Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
Recalling firmMarksans Pharma Limited
DistributionNationwide
Quantitya) 64,590 b) 23,834 c) 109,125 d) 27839 bottles
Recall initiated2020-10-02
Report date2020-11-11
Recall completed2024-02-21
Recall numberD-0061-2021
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.