Recalls / Class II
Class IID-0366-2022
Product
Metformin 750 mg Extended Release NDC # 70518-2920-00
- Affected 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
Why it was recalled
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 56 Blister Cards
- Distribution pattern
- Product was distributed to one direct account in PA.
Timeline
- Recall initiated
- 2021-12-30
- FDA classified
- 2022-01-11
- Posted by FDA
- 2022-01-19
- Terminated
- 2022-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0366-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.