NDC 65757-300 – Vivitrol
· Kit
Product NDC65757-300
Product details
- Brand name
- Vivitrol
- Generic name
- Naltrexone
- Labeler
- Alkermes, Inc.
- Dosage form
- Kit
- Marketing category
- NDA · NDA021897
- Marketed since
- June 13, 2006
- Listing expires
- December 31, 2027
Active ingredients
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 65757-300-01 | 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03) | Jun 13, 2006 |
Recalls mentioning this NDC
- D-0119-2020 Oct 9, 2019 · Class II
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… - D-1846-2019 Sep 4, 2019 · Class II
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… - D-1556-2014 Sep 3, 2014 · Class II
Customer complaints for failure to deliver the dose. - D-819-2013 Jul 31, 2013 · Class II
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Other Vivitrol products
- 65757-301 · Kit · Alkermes, Inc.