Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a). N102851902, Exp. 04/30/2021 b). D102851801, Exp. 04/2021 c). N102851901, Exp. 11/30/2021 N102851903, Exp. 12/31/2021 N102851906, Exp. 03/31/2022 d). N102851904, Exp. 02/28/2022 N102851905, Exp. 12/31/2021 e). C102851901, Exp. 11/30/2021 C102851902, Exp. 11/30/2021 C102851903, Exp. 11/30/2021 C102851904, Exp. 05/31/2021 C102851905, Exp. 02/28/2022 C102851906, Exp. 02/28/2022 C102851907, Exp. 03/31/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Denton Pharma, Inc.
- Reason for Recall:
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Product Codes/Lot Numbers:
a). N102851902, Exp. 04/30/2021 b). D102851801, Exp. 04/2021 c). N102851901, Exp. 11/30/2021 N102851903, Exp. 12/31/2021 N102851906, Exp. 03/31/2022 d). N102851904, Exp. 02/28/2022 N102851905, Exp. 12/31/2021 e). C102851901, Exp. 11/30/2021 C102851902, Exp. 11/30/2021 C102851903, Exp. 11/30/2021 C102851904, Exp. 05/31/2021 C102851905, Exp. 02/28/2022 C102851906, Exp. 02/28/2022 C102851907, Exp. 03/31/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0794-2020
Related Recalls
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: Presence of NDMA impurity detected in product.