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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Slate Run Pharmaceuticals
- Reason for Recall:
- CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0278-2025
Related Recalls
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
Slate Run Pharmaceuticals
Class I - Dangerous
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.