Prescription Drug Recall: Technetium Tc99m Mertiatide Kits - Dissolution Specification Failure
Sun Pharmaceutical recalls 1870 kits of Technetium Tc99m Mertiatide due to failed dissolution specifications in a component used for production. The affected lot was distributed nationwide.
What this means for you
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: FDA Class II classification indicates a potential for harm. No illnesses or injuries have been reported, but failed dissolution specifications represent a risk-of-harm product that could affect the drug's quality and effectiveness, warranting a High severity rating.
Plain-English summary
Sun Pharmaceutical Industries is recalling 1870 kits for the preparation of Technetium Tc99m Mertiatide (Betiatide), an intravenous prescription drug. The recalled product is Lot #AD70995 with an expiration date of October 31, 2025, and was distributed nationwide in the United States.
The recall was initiated due to failed dissolution specifications with out-of-specification (OOS) observations for sulphate content in Sodium Tartrate Dihydrate, a component used in the production of Mertiatide. Dissolution specifications are critical for ensuring the drug's effectiveness; the failure to meet these specifications could impact the final product quality.
Healthcare providers, pharmacists, and patients in possession of the recalled lot should verify their product against Lot #AD70995. The manufacturer and FDA are investigating the root cause of the specification failure.
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
- Hazard
- failed-dissolution-specification
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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