# FDA recall D-0430-2019

> **Advanced Pharma Inc.** · Class II · drug recall initiated 2019-01-15.

## Product

HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe,  Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65

## Reason for recall

Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)

## Distribution

TX, WA

## Key facts

- **Recall number:** D-0430-2019
- **Recalling firm:** Advanced Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-15
- **Report date:** 2019-01-30
- **Termination date:** 2019-05-01

- **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-0430-2019

## Citation

> AI Analytics. FDA recall D-0430-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0430-2019. Source: US FDA. Licensed CC0.

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