FDAFDA · Food and drugs·Recall number D-0366-2022
Metformin 750 mg Extended Release NDC # 70518-2920-00
Published January 19, 2022 · Recall initiated: December 30, 2021
Status when published: Terminated — 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) levels in excess of the Acceptable Daily Intake Limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to one direct account in PA.
- Lot
- Lot # J0511265-021121, exp. date 02/28/2022 J0499451-122220, exp. date 01/31/2022 J0496563-120820, exp. date 12/31/2021 J0495111-120120, exp. date 12/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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