Reported Jul 22, 2020 · Ongoing
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle…
Granules Pharmaceuticals 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: Granules Pharmaceuticals Inc · 3701 Concorde Pkwy · Chantilly, VA · 20151-1126
Is this the product you have?
- Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05)
- Manufactured forGranules Pharmaceutical Inc., Chantilly, VA
- Manufactured byGranules India Limited, Hyderabad - 500-081, India
- Lot codes and dates
- a) 100 countb) 500 count 4920005B/Jun-21
4920003A/May-214920004A/Jun-214920005A/Jun-214920009A/Nov-214920010A/May-224920011A/Jun-224920012A/Jun-224920013A/Jul-224920014A/Jul-224920015A/Aug-224920016A/Jan-23
- a) 100 count
- Amount recalled
- a) 476,073 bottles; b) 2,100 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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