FDA Drug recall D-0460-2019
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,…
- FDA Drug
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,… by Promise Pharmacy, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0460-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-17 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Promise Pharmacy |
| Distribution | US |
Product
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: 06182018@5 BUD: 12/15/2018; 07102018@5 BUD: 1/6/2018; 08212018@8 BUD: 2/17/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0460-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.