September 2025 FDA Recall Kit For The Preparation Of Technetium Tc99m Mertiatide by Sun Pharmaceutical Industries Inc (D-0658-2025 - Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.)

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on September 3, 2025 for the product Kit For The Preparation Of Technetium Tc99m Mertiatide. The FDA reported the reason for recall as failed dissolution specifications-out of specification (oos) observation for sulphate in sodium tartrate dihydrate used for the production of mertiatide.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0658-2025

Reason for Recall
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Initiated
09-03-2025
Reported
09-24-2025
Quantity
1870 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97460
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

Batch or Lot Expiration Information

Lot# AD70995; Exp 10/31/2025

Affected Packages Involved in this Recall

45567-0655-1 Kit For The Preparation Of Technetium Tc99m Mertiatide