# FDA recall D-819-2013

> **Alkermes, Inc.** · Class II · drug recall initiated 2012-11-06.

## Product

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,

## Reason for recall

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-819-2013
- **Recalling firm:** Alkermes, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-11-06
- **Report date:** 2013-07-31
- **Termination date:** 2013-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-819-2013

## Citation

> AI Analytics. FDA recall D-819-2013. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-819-2013. Source: US FDA. Licensed CC0.

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