Ranitidine Tablets recall: Nitrosamine Impurity
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Why was Ranitidine Tablets recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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?
7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
- Product
- RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
- Recalling firm
- Granules India Limited
- Quantity
- 23,090,000 tablets
- Distribution
- OR, NY, NJ
- Recall date
- January 8, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)