Metformin 750 mg Extended Release NDC # 70518-2920-00
FDA Recall #D-0366-2022 — Class II — December 30, 2021
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.
Recalling Firm
RemedyRepack Inc. — Indiana, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
56 Blister Cards
Distribution
Product was distributed to one direct account in PA.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated