# FDA recall D-1334-2022

> **Teva Pharmaceuticals USA Inc** · Class III · drug recall initiated 2022-07-22.

## Product

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

## Reason for recall

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

## Distribution

Distributed in Ohio

## Key facts

- **Recall number:** D-1334-2022
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-22
- **Report date:** 2022-08-17
- **Termination date:** 2023-04-12

- **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-1334-2022

## Citation

> AI Analytics. FDA recall D-1334-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1334-2022. Source: US FDA. Licensed CC0.

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