Why it was recalled
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product description
Metformin 750 mg Extended Release NDC # 70518-2920-00
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to one direct account in PA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0366-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 56 Blister Cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0366-2022, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 89331
- Address
- 625 Kolter Dr Ste 4
- 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
- Postal code
- 15701-3571
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0366-2022
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 56 Blister Cards
- Termination date
- Mar 28, 2022
- Reason for recall
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin 750 mg Extended Release NDC # 70518-2920-00
- Distribution pattern
- Product was distributed to one direct account in PA.
- Recall initiation date
- Dec 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 11, 2022