Drug product

HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

D-0461-2019

December 17, 2018

Class II

Product summary

Firm: Promise Pharmacy, LLC
Event: Event 81810
Status: Terminated
Classification: Class II
Quantity: 2595 vials
Official record key: drug-enforcement:D-0461-2019

Official wording

Reason: Lack of sterility assurance.

Code information: 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

Distribution pattern: Nationwide in the USA.

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of sterility