HCG — Class II drug recall D-0461-2019
Terminated recall by Promise Pharmacy, LLC, reported 2019-02-20, distributed nationwide. Lack of sterility assurance.
| Recall number | D-0461-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Promise Pharmacy, LLC, Palm Harbor, FL, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-02-08 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 2,595 vials |
| Reason classes | sterility |
| Expiration dates | 2018-12-22, 2019-01-09, 2019-01-22, 2019-02-17, 2019-02-23, 2019-02-28 |
Product
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for recall
Lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0461-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.