FDA recall D-0458-2019
Promise Pharmacy, LLC · Class II · drug
Product
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 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-0458-2019