FDAFDA · Food and drugs·Recall number D-0278-2025
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
Published March 26, 2025 · Recall initiated: March 7, 2025
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Slate Run Pharmaceuticals
- Distributor
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Lot
- Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.