FDAFDA · Food and drugs·Recall number D-0641-2020
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
Published January 15, 2020 · Recall initiated: December 17, 2019
Status when published: Ongoing — 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 · Press Release
Recall details
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Natiowide
- Lot
- 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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