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Drug FDA Class II Ongoing cGMP deviation

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

Dr. Reddy's Laboratories, Inc. Published Nov 6, 2024

Risk level

Class II

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

Severity score 60/100

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 Dr. Reddy's Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Hazards

N-nitroso-cinacalcet · primary

Affected products (1)

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

CINACALCET · 10584 bottles

NDC: 43598-367, 43598-368, 43598-369, 43598-367-30, 43598-367-05, 43598-368-30, 43598-368-05, 43598-369-30, 43598-369-05
Lot codes: T2201443
Code info: Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 9, 2024
  2. Published
    Nov 6, 2024
Recall number
D-0028-2025
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.