Reported Jul 1, 2020 · Terminated
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles,…
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 500 mg Rx Only 100 Tablets bottles
- Manufactured for
Time-Cap LabsInc. 7 Michael Avenue FarmingdaleNY 11735
- USA Manufactured byMarksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
- Lot codes and dates
XP9004exp 12/2020
- Amount recalled
- 11279 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA analysis detected 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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