FDAFDA · Food and drugs·Recall number D-0056-2021
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
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
- N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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