Recall archive / FDA drug enforcement
Metformin 750 mg Extended Release NDC # 70518-2920-00 — FDA record D-0366-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 30, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Metformin 750 mg Extended Release NDC # 70518-2920-00
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 56 Blister Cards
- Agency-reported status
- Terminated
- Source record identifier
- D-0366-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to one direct account in PA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 19, 2022
- Recall initiation date
- Dec 30, 2021
- Center classification date
- Jan 11, 2022
- Termination date
- Mar 28, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.