D-0366-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 19, 2022
- Initiation Date
- December 30, 2021
- Termination Date
- March 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 Blister Cards
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.
Distribution Pattern
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