FDA-Drug2020-11-11Class II
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Denton Pharma, Inc.
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Sold states
Indiana - Nationwide.
Affected count
N/A
Manufactured in
119 Creamery Rd, N/A, North Blenheim, NY, United States
Products
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2021Don't want to check this manually?
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