# FDA recall D-0744-2022

> **Vitae Enim Vitae Scientific, Inc.** · Class II · drug recall initiated 2022-03-14.

## Product

PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.

## 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 in the U.S.A

## Key facts

- **Recall number:** D-0744-2022
- **Recalling firm:** Vitae Enim Vitae Scientific, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-14
- **Report date:** 2022-04-13
- **Termination date:** 2024-08-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0744-2022

## Citation

> AI Analytics. FDA recall D-0744-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0744-2022. Source: US FDA. Licensed CC0.

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