Safety Alert: Class II: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
healthClass IIRecalled on Sep 24, 2025
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc
🔢 1870 kits
Sold At: SUN PHARMACEUTICAL INDUSTRIES INC(US Nationwide.)
Recall #: FDA-DRUG-D-0658-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot# AD70995; Exp 10/31/2025
Get AI-Powered Summary
Premium members get instant insights to help you understand recalls faster
Instant 1-3 sentence summary
Quick action bullets
Clear guidance on what to do
Summary
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact SUN PHARMACEUTICAL INDUSTRIES INC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.