Class II
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- Recall number
- D-0279-2025
- Report date
- March 26, 2025
- Classification
- Class II
- Status in dataset
- Completed
- Recalling firm
- Slate Run Pharmaceuticals
- Generic names
- Not provided
- Brand names
- Not provided
- Product NDCs
- Not provided
Code and lot information
Lot # 109797, Exp 11/2026
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.