Sun Pharmaceutical recalls Mertiatide kits with failed dissolution specifications due to sulfate issues in Sodium Tartrate Dihydrate. This affects specific lots and NDC numbers. Contact for details.
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Sun Pharmaceutical is recalling kits for preparing Mertiatide, a prescription drug, because the manufacturing process had a failure in dissolution specifications for sulfate levels. This could lead to unsafe drug preparation if used without correction.
The kit uses Sodium Tartrate Dihydrate, which had failed dissolution specifications for sulfate levels. This could result in improper drug concentration, potentially causing unsafe medical outcomes if used without correction.
Prescription drug users who have the specific kit with NDC 45567-0655-1 and lot number AD70995. Healthcare providers using this kit for medical procedures are most at risk.
Check for the NDC code 45567-0655-1 and lot number AD70995 on the kit. This kit was manufactured in Billerica, MA and expires October 31, 2025.
Look for the NDC code 45567-0655-1 and lot number AD70995 on the kit label.
The recall indicates a failed dissolution specification for sulfate levels, so it is not safe to use without correction. The remedy is not stated in the record.
The recall record does not specify a remedy, so contact Sun Pharmaceutical for guidance.
Check for the NDC code 45567-0655-1 and lot number AD70995 on the kit label.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0658-2025 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0658-2025 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
