Reported Nov 11, 2020 · Terminated
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only…
Marksans Pharma Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Marksans Pharma Limited · & L - 83 Plots L - 82 · Vasco Da Gama, N/A · N/A
Is this the product you have?
- Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles
- Rx Only Manufactured for
Time-Cap LabsInc. 7 Michael Avenue FarmingdaleNY 11735
- USA Manufactured byMarksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
- Lot codes and dates
M125E Oct-20D001FC084F Nov-20F073FE063F Jan-21F072F Mar-21J002FJ087F Apr-21K080FL056F Jun 21M046FJul-219R9001Oct-219R9002Nov-219R00019R0002 Dec-219R0003XR00169R00049R0005 Mar-229R00069R0007 Apr-22
- Amount recalled
- 368,976 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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