FDAClass IINovember 13, 2019

Dr. Reddy's Ranitidine Tablets recall: Nitrosamine Impurity

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Why was Dr. Reddy's Ranitidine Tablets recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

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?

Batch Numbers: All lots within expiry.

Product
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
N/A
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Recall date
November 13, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls