Drug FDA Class II Completed cGMP deviation

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

Slate Run Pharmaceuticals Published Mar 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Slate Run Pharmaceuticals or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

N-nitroso impurity · primary

Affected products (1)

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

56,790 bottles

Lot codes: 07711

Code info: Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026

Affected areas

Nationwide

Timeline

Initiated

Mar 7, 2025
Published

Mar 26, 2025

Recall number: D-0278-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.