# FDA recall D-0164-2025

> **Curium US, LLC** · Class II · drug recall initiated 2024-11-26.

## Product

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate -  0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg.  The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only,  Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40

## Reason for recall

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

## Distribution

Nationwide USA and Canada.

## Key facts

- **Recall number:** D-0164-2025
- **Recalling firm:** Curium US, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-11-26
- **Report date:** 2025-01-01
- **Termination date:** 2025-10-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maryland Heights, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0164-2025

## Citation

> AI Analytics. FDA recall D-0164-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0164-2025. Source: US FDA. Licensed CC0.

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