Glenmark Ranitidine Tablets USP 300 mg recall: Nitrosamine Impurity
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India…
Why was Glenmark Ranitidine Tablets USP 300 mg recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
- Product
- Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 98,988 bottles
- Distribution
- Natiowide
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)