Metformin 750 mg Extended Release recall: Nitrosamine Impurity
Metformin 750 mg Extended Release NDC # 70518-2920-00
Why was Metformin 750 mg Extended Release recalled?
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Metformin 750 mg Extended Release NDC # 70518-2920-00
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 56 Blister Cards
- Distribution
- Product was distributed to one direct account in PA.
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)