FDA-Drug2020-11-11Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
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
a) 684; b) 432; c) 3668; d) 2029 bottles
Manufactured in
119 Creamery Rd, N/A, North Blenheim, NY, United States
Products
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0057-2021Don't want to check this manually?
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