# FDA recall D-0988-2022

> **Teva Pharmaceuticals USA Inc** · Class III · drug recall initiated 2022-05-18.

## Product

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054,  Vial NDC 0703-1501-01

## Reason for recall

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

## Distribution

Product was distributed nationwide in the US Market

## Key facts

- **Recall number:** D-0988-2022
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-18
- **Report date:** 2022-06-15
- **Termination date:** 2023-12-08

- **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-0988-2022

## Citation

> AI Analytics. FDA recall D-0988-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0988-2022. Source: US FDA. Licensed CC0.

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