# FDA recall D-0033-2018

> **AbbVie Inc.** · Class III · drug recall initiated 2017-09-08.

## Product

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by:  AbbVie Inc., North Chicago, IL 60064 USA.  NDC: 0051-8462-33

## Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

## Distribution

AZ

## Key facts

- **Recall number:** D-0033-2018
- **Recalling firm:** AbbVie Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-08
- **Report date:** 2017-11-01
- **Termination date:** 2018-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2018

## Citation

> AI Analytics. FDA recall D-0033-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0033-2018. Source: US FDA. Licensed CC0.

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