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, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
Lot numbers, UPCs & expiration codes
HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020
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-1393-2020
- 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-1393-2020, 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
- HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020
- Postal code
- 11719-9509
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1393-2020
- 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, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
- Distribution pattern
- Nationwide
- Recall initiation date
- May 29, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jun 25, 2020