Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz recall: Nitrosamine Impurity
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Why was Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz 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?
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
- Product
- Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Quantity
- N/A
- Distribution
- Product was distributed throughout the United States.
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)