Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Product description
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Lot numbers, UPCs & expiration codes
Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
Where it was sold
Product was distributed to one customer 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-0050-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 11, 2020
- FDA report date
- Nov 4, 2020
- Quantity
- 79/30 count blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0050-2021, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 86624
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot Numbers: J0423350-121219 exp. date 12/31/2020 J0434828-020320 exp. date 02/28/2021 J0442511-031220 exp. date 03/31/2021 J0448429-040920 exp. date 04/30/2021 J0472499-081020, J0472532-081020 exp. date 08/31/2021
- Postal code
- 15701-3571
- Report date
- Nov 4, 2020
- Product type
- Drugs
- Recall number
- D-0050-2021
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 79/30 count blister cards
- Termination date
- Feb 24, 2021
- Reason for recall
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
- Distribution pattern
- Product was distributed to one customer in PA.
- Recall initiation date
- Oct 11, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2020