FDAFDA · Food and drugs·Recall number D-0795-2020
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
Published January 29, 2020 · Recall initiated: December 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denton Pharma, Inc.
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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