# FDA recall D-0375-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2021-04-26.

## Product

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0375-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-26
- **Report date:** 2021-05-26
- **Termination date:** 2024-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0375-2021

## Citation

> AI Analytics. FDA recall D-0375-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0375-2021. Source: US FDA. Licensed CC0.

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