# FDA recall D-0781-2022

> **North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding** · Class II · drug recall initiated 2022-04-05.

## Product

Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only,  Farmakeio 1736 N Greenville Ave Richardson, TX 75081

## Reason for recall

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

## Distribution

Nationwide within United States

## Key facts

- **Recall number:** D-0781-2022
- **Recalling firm:** North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-05
- **Report date:** 2022-04-27
- **Termination date:** 2023-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richardson, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0781-2022

## Citation

> AI Analytics. FDA recall D-0781-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0781-2022. Source: US FDA. Licensed CC0.

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