# FDA recall D-0499-2019

> **Advanced Pharma Inc.** · Class III · drug recall initiated 2019-02-06.

## Product

Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only,  Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.

## Reason for recall

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0499-2019
- **Recalling firm:** Advanced Pharma Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-06
- **Report date:** 2019-02-27
- **Termination date:** 2019-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0499-2019

## Citation

> AI Analytics. FDA recall D-0499-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0499-2019. Source: US FDA. Licensed CC0.

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