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
Reported: January 15, 2020 Initiated: December 17, 2019 #D-0641-2020
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.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 98,988 bottles
- Distribution
- Natiowide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 98,988 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2020. Severity: Moderate. Recall number: D-0641-2020.
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