# FDA recall D-0172-2017

> **West-Ward Pharmaceuticals Corp.** · Class III · drug recall initiated 2016-11-17.

## Product

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only,  Mfd: Hikma Farmaceutica (Portugal,) SA   Distributed by: Westward Eatowntown NJ  07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01

## Reason for recall

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.

## Distribution

US nationwide

## Key facts

- **Recall number:** D-0172-2017
- **Recalling firm:** West-Ward Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-17
- **Report date:** 2016-12-14
- **Termination date:** 2018-04-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2017

## Citation

> AI Analytics. FDA recall D-0172-2017. Retrieved 2026-09-14 from https://api.ai-analytics.org/recall/D-0172-2017. Source: US FDA. Licensed CC0.

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