Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 2019-1002T, 2019-1003T, Exp 05/2021
Where it was sold
Nationwide USA and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0119-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2019
- FDA report date
- Oct 9, 2019
- Quantity
- 16,231 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alkermes, Inc.
Original FDA data
Every field from FDA enforcement report D-0119-2020, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 83878
- Address
- 852 Winter St
- Code information
- Lot 2019-1002T, 2019-1003T, Exp 05/2021
- Postal code
- 02451-1420
- Report date
- Oct 9, 2019
- Product type
- Drugs
- Recall number
- D-0119-2020
- Classification
- Class II
- Recalling firm
- Alkermes, Inc.
- Product quantity
- 16,231 kits
- Termination date
- Feb 19, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA and Canada
- Recall initiation date
- Sep 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 2, 2019