Metformin 750 mg Extended Release NDC # 70518-2920-00

FDA recall notice · announced January 19, 2022 · Remedyrepack

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Product was distributed to one direct account in PA.
Lot/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
Quantity: 56 Blister Cards
Status: Terminated
Products in this recall event:
- Metformin 750 mg Extended Release NDC # 70518-2920-00 (D-0366-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.