# FDA recall D-0119-2020

> **Alkermes, Inc.** · Class II · drug recall initiated 2019-09-26.

## Product

Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01

## Reason for recall

Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

## Distribution

Nationwide USA and Canada

## Key facts

- **Recall number:** D-0119-2020
- **Recalling firm:** Alkermes, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-26
- **Report date:** 2019-10-09
- **Termination date:** 2021-02-19

- **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-0119-2020

## Citation

> AI Analytics. FDA recall D-0119-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0119-2020. Source: US FDA. Licensed CC0.

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