Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product description
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Lot numbers, UPCs & expiration codes
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Where it was sold
Product was distributed throughout the United States.
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-0616-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 22, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0616-2020, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 84353
- Address
- 50 Horseblock Rd
- Code information
- HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
- Postal code
- 11719-9509
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0616-2020
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Reason for recall
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 22, 2019
- Initial firm notification
- Press Release
- Center classification date
- Dec 9, 2019