Technetium mertiatide kits recalled after out-of-specification sulphate in a raw material
Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a radiopharmaceutical kit failing its specification is a potential harm and no injuries are reported.
Plain-English summary
The Kit for the Preparation of Technetium Tc 99m Mertiatide, available on prescription only, manufactured by Sun Pharmaceutical Industries, Inc. of Billerica, Massachusetts, NDC 45567-0655-1, is being recalled. The affected product is lot AD70995 with an expiry of 10/31/2025, and the recall covers 1,870 kits distributed nationwide.
The recall was issued because the product failed dissolution specifications, following an out-of-specification observation for sulphate in the sodium tartrate dihydrate used for the production of mertiatide. The FDA classified the action as Class II.
Nuclear medicine departments holding this lot should quarantine it, stop using it, and follow the manufacturer's instructions for return.
The recalled product
- Product
- KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE)
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Radiopharmaceutical
- Affected units
- 1,870
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# AD70995
- Exp 10/31/2025
Distribution
Distributed nationwide across the United States.
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