Drug recall
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus…
FDA recall event 96433 · Class II · Slate Run Pharmaceuticals
Key facts
| Event ID | 96433 |
|---|---|
| Recall numbers | D-0278-2025, D-0279-2025 |
| Recalling firm | Slate Run Pharmaceuticals |
| Product type | Drugs |
| Products | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04, 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. |
| Initiation date | Mar 7, 2025 |
| Report date | Mar 26, 2025 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3012729077 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: