FDA recall D-1029-2019
Advanced Pharma Inc. · Class II · drug
Product
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-03-13
- Report date
- 2019-03-27
- Termination date
- 2020-01-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Houston, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1029-2019