Class II
Ongoing
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
This recall is currently active, issued November 11, 2020. It was issued by Denton Pharma, Inc..
- Company
- Denton Pharma, Inc.
- Recall Initiated
- October 8, 2020
- Posted
- November 11, 2020
- Recall Number
- D-0056-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- North Blenheim, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Distribution
Indiana - Nationwide.
Lot / Code Info
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
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