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Drug FDA Class II Ongoing cGMP deviation

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

SUN PHARMACEUTICAL INDUSTRIES INC Published Sep 24, 2025

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 SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Hazards

Sulphate contamination in Sodium Tartrate Dihydrate · primary

Affected products (1)

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE · 1870 kits

NDC: 45567-0655, 45567-0655-1
Lot codes: AD70995
Code info: Lot# AD70995; Exp 10/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 3, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0658-2025
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.