FDAFDA · Food and drugs·Recall number D-0057-2021
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
Published November 11, 2020 · Recall initiated: October 8, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denton Pharma, Inc.
- Distributor
- Indiana - Nationwide.
- Lot
- a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 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; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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