Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product description
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Lot numbers, UPCs & expiration codes
06648001A 11/2019 06648003A 4/2020 06649001A 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-0614-2020
- 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-0614-2020, 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
- 06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
- Postal code
- 11719-9509
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0614-2020
- 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 Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
- 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