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Class II · ModerateActive recall

Kit For The Preparation Of Technetium Tc99M Mertiatide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# AD70995; Exp 10/31/2025
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries, Inc. Billerica, MA 01821
Brand nameKIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE
Generic nameBETIATIDE
Active ingredient(s)BETIATIDE
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC45567-0655-1
Show the full FDA record
Full product labelKit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionUS Nationwide.
Quantity1870 kits
Recall initiated2025-09-03
Report date2025-09-24
Recall completed—
Recall numberD-0658-2025
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.