Reported Nov 11, 2020 · Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum…
Nostrum Laboratories 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: Nostrum Laboratories Inc · 1800 N Topping Ave · Kansas City, MO · 64120-1228
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only
- Manufactured byNostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
- Lot codes and dates
MET100201MET100401 EXP 05/2022
- Amount recalled
- 20,872 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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