FDA Recall D-0658-2025

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 253 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot# AD70995; Exp 10/31/2025

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 record

Recall number: D-0658-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2025-09-03
Classified by FDA Center: 2025-09-22
FDA published: 2025-09-24
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE
Generic name(s): BETIATIDE
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 45567-0655
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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