Recalls / Class II
Class IID-0463-2019
Product
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Affected lot / code info
- Lots: 07102018@4 BUD: 1/6/2019; 09142018@6 BUD: 3/13/2019; 10052018@4 BUD: 4/3/2019; 11062018@1 BUD: 5/5/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Promise Pharmacy, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31818 Us Highway 19 N, N/A, Palm Harbor, Florida 34684-3713
Distribution
- Quantity
- 266 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-12-17
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-02-20
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0463-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.