Why it was recalled
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Product 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
Lot numbers, UPCs & expiration codes
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Where it was sold
Product was distributed to 8 distributors who may have further distribute the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0278-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 7, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- 56,790 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Slate Run Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0278-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Completed
- Country
- United States
- Event ID
- 96433
- Address
- 277 W Nationwide Blvd Ste 260
- Code information
- Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
- Postal code
- 43215-0169
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0278-2025
- Classification
- Class II
- Recalling firm
- Slate Run Pharmaceuticals
- Product quantity
- 56,790 bottles
- Reason for recall
- CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Recall initiation date
- Mar 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 17, 2025