PlainRecalls
FDA Drug Moderate Class II Terminated

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.