Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkermes, Inc | Wilmington, OH, United States | Makes it | Problems found, fixed voluntarilyOct 19, 2023 · 10 inspections |
| Packaging Coordinators, LLC | Philadelphia, PA, United States | Packages it and labels it | Problems found, fixed voluntarilyJan 31, 2025 · 6 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Recalls
- Sep 26, 2019 · Class II · Alkermes, Inc.
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.
Lots: Lot 2019-1002T, 2019-1003T, Exp 05/2021 - Aug 8, 2019 · Class II · Alkermes Inc
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.
Lots: Lot 2018-3010T Exp 8/2021 - Mar 4, 2014 · Class II · Alkermes, Inc.
Customer complaints for failure to deliver the dose.
Lots: Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01. - Nov 6, 2012 · Class II · Alkermes, Inc.
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Lots: Individual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Naltrexone: every company that makes it
- Form
- kit
- Strength
- 380 mg per 4 mL
- Approval
- NDA NDA021897
- On the market since
- Jun 13, 2006
- Package NDCs
65757-301-0165757-303-0265757-305-03- Official label
- DailyMed (National Library of Medicine), updated May 31, 2026
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