D-0641-2020 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,988 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Natiowide
Code Information
7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490