Recalls / Class II
Class IID-0461-2019
Product
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Affected lot / code info
- Lots: 06252018@1 BUD: 12/22/2018; 07132018@7 BUD: 1/9/2019; 07262018@2 BUD: 1/22/2019; 08212018@7 BUD: 2/17/2019; 08272018@2 BUD: 2/23/2019; 09052018@2 BUD: 2/28/2019
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
- 2595 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-0461-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.