Class II · Moderate risk
Naltrexone Hydrochloride Tablets
cGMP deviations: Temperature abuse
VIVITROL (naltrexone for extended-release injectable suspension)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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,
Affected NDCs
65757-0300-01
65757-0303-02
Compare with the code on your package — it is the most precise check available.
Drug: Naltrexone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vivitrol naltrexone NDC 65757-0300 |
Kit | Alkermes, Inc. | Rx |
- Recalling firm
- Alkermes, Inc.
- NDC code
- 65757-303-02
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-819-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Naltrexone recalls
See all
Class II · Moderate risk
Naltrexone 4.5 mg/mL Suspension 30 mL bottle
Lack of Processing Control
Class II · Moderate risk
Naltrexone
Lack of Processing Control
Class II · Moderate risk
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
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.
Other recalls by Alkermes, Inc.
All 2012 recalls
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
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.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
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.
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Customer complaints for failure to deliver the dose.
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