Drug Enforcement D-0658-2025

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

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

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Product Information

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
Product quantity
1870 kits
Reason for recall
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0658-2025
Event ID
97460
Recall initiation date
September 3, 2025
Center classification date
September 22, 2025
Code info
Lot# AD70995; Exp 10/31/2025
More code info
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