Ranitidine Tablets recall: Nitrosamine Impurity
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
Why was 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
- Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) 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)