# FDA recall D-0545-2018

> **ALLERGAN** · Class II · drug recall initiated 2017-12-13.

## Product

INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.

## Reason for recall

Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.

## Distribution

Product was distributed nationwide in the USA.

## Key facts

- **Recall number:** D-0545-2018
- **Recalling firm:** ALLERGAN
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-13
- **Report date:** 2018-03-07
- **Termination date:** 2020-04-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2018

## Citation

> AI Analytics. FDA recall D-0545-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0545-2018. Source: US FDA. Licensed CC0.

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