Drug Enforcement D-0278-2025

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Status

Ongoing

Classification

Class II

Report Date

March 26, 2025

Termination Date

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Product Information

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
Product quantity
56,790 bottles
Reason for recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Product was distributed to 8 distributors who may have further distribute the product nationwide.

Location & Firm

Recalling firm
Slate Run Pharmaceuticals
Address
277 W Nationwide Blvd Ste 260, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0278-2025
Event ID
96433
Recall initiation date
March 7, 2025
Center classification date
March 17, 2025
Code info
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
More code info
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