FDA Drugs recall ·
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr recall
- Recall number
- D-0278-2025
- Date
- (initiated March 7, 2025)
- Company / brand
- Slate Run Pharmaceuticals
277 W Nationwide Blvd Ste 260, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 56,790 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0278-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.