FDA recall D-0940-2017
Alvogen, Inc · Class II · drug
Product
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-06-16
- Report date
- 2017-07-12
- Termination date
- 2019-10-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pine Brook, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0940-2017