Dr. Reddy's Ranitidine Capsules recall: Nitrosamine Impurity
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
Why was Dr. Reddy's Ranitidine Capsules 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 Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
- 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)