Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product description
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
Lot numbers, UPCs & expiration codes
HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
Where it was sold
Nationwide
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-1348-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 29, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-1348-2020, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 85781
- Address
- 50 Horseblock Rd
- Code information
- HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
- Postal code
- 11719-9509
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1348-2020
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
- Distribution pattern
- Nationwide
- Recall initiation date
- May 29, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jun 25, 2020