# FDA recall D-0069-2023

> **Acella Pharmaceuticals, LLC** · Class III · drug recall initiated 2022-11-14.

## Product

Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

## Reason for recall

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0069-2023
- **Recalling firm:** Acella Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-11-14
- **Report date:** 2022-11-30
- **Termination date:** 2024-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2023

## Citation

> AI Analytics. FDA recall D-0069-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0069-2023. Source: US FDA. Licensed CC0.

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