FDA recall D-0431-2019
Promise Pharmacy, LLC · Class II · drug
Product
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Reason for recall
Lack of sterility assurance.
Distribution
Nationwide in the USA.
Key facts
- Status
- Terminated
- Initiation date
- 2018-12-17
- Report date
- 2019-02-20
- Termination date
- 2021-03-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Palm Harbor, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2019