Cinacalcet Hydrochloride Tablets 30 mg recall: Nitrosamine Impurity
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma…
Why was Cinacalcet Hydrochloride Tablets 30 mg recalled?
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
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?
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
- Product
- Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma…
- Recalling firm
- Slate Run Pharmaceuticals
- Quantity
- 56,790 bottles
- Distribution
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)