WhichRecall
Class IIReported 2025-09-24

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

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall

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

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Recall Number
D-0658-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-03
Reported
2025-09-24
Distribution
US Nationwide.
Code Info
Lot# AD70995; Exp 10/31/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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