Class II
Terminated
Metformin 750 mg Extended Release NDC # 70518-2920-00
- Company
- Remedyrepack Inc.
- Recall Initiated
- December 30, 2021
- Posted
- January 19, 2022
- Recall Number
- D-0366-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 56 Blister Cards
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Product was distributed to one direct account in PA.
Lot / Code Info
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
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