← FDA ENFORCEMENT
D-0658-2025Class II

SUN PHARMACEUTICAL INDUSTRIES INC

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Ongoing
Report date
2025-09-24
Distribution
US Nationwide.
Firm state
NJ
Product quantity
1870 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot# AD70995; Exp 10/31/2025

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.