Ranitidine 150 mg tablets recall: Nitrosamine Impurity
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
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?
P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
- Product
- Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
- Recalling firm
- AAA Pharmaceutical, Inc.
- Quantity
- 31,536 (130-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)