Ranitidine 150 mg tablets recall: Nitrosamine Impurity
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Why was Ranitidine 150 mg tablets recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
- Product
- Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
- Recalling firm
- AAA Pharmaceutical, Inc.
- Quantity
- 34,272 (24-count bottles)
- Distribution
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)