Reported Nov 11, 2020 · Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc.,…
Denton Pharma, Inc.
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: Denton Pharma, Inc. · 119 Creamery Rd · North Blenheim, NY · 12131-1613
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc
- Repackaged ByNorthwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
- Lot codes and dates
N107411901N107411903N107411904N107411905N107411906exp 11/30/2020N107411907N107412001exp 4/30/2021N107412002N107412004exp 11/30/2021N107412003exp 7/31/2021
- Amount recalled
- N/A
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
- IN
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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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