Reported Nov 11, 2020 · Ongoing
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC…
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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 30 count (NDC 70934-309-30) |
| 2 | 60 count (NDC 70934-309-60) |
| 3 | 90 count (70934-309-90) |
| 4 | 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 N107051905, exp 10/31/2020 2 N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020 3 N107052001 6/30/2021 4 N107052010, N107052008, N107052004, exp 9/30/2021 5 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021 6 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021 7 C107052003, C107052005, N107052003 exp 9/30/2021 - Amount recalled
- a) 684; b) 432; c) 3668; d) 2029 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
- 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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