Metformin 750 mg Extended Release NDC # 70518-2920-00
Reported: January 19, 2022 Initiated: December 30, 2021 #D-0366-2022
Product Description
Metformin 750 mg Extended Release NDC # 70518-2920-00
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 56 Blister Cards
- Distribution
- Product was distributed to one direct account in PA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Metformin 750 mg Extended Release NDC # 70518-2920-00. Recalled by RemedyRepack Inc.. Units affected: 56 Blister Cards.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 19, 2022. Severity: Moderate. Recall number: D-0366-2022.
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