Ranitidine Tablets recall: Nitrosamine Impurity
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
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?
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
- Product
- Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
- 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)