Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Lot numbers, UPCs & expiration codes
a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022
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-0795-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Jan 29, 2020
- Quantity
- 467 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denton Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0795-2020, exactly as published.
Show all FDA fields
- City
- North Blenheim
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84657
- Address
- 119 Creamery Rd
- Code information
- a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022
- Postal code
- 12131-1613
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0795-2020
- Classification
- Class II
- Recalling firm
- Denton Pharma, Inc.
- Product quantity
- 467 bottles
- Termination date
- Oct 5, 2023
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2020