Cinacalcet Tablets recall: Impurity Out of Spec
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Why was Cinacalcet Tablets recalled?
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
- Product
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 10584 bottles
- Distribution
- USA Nationwide.
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)