FDA recall D-1230-2019
CMC Enterprise Pharmacy · Class II · drug
Product
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason for recall
Lack of sterility assurance.
Distribution
NC
Key facts
- Status
- Terminated
- Initiation date
- 2019-04-12
- Report date
- 2019-05-01
- Termination date
- 2019-10-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Charlotte, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1230-2019