FDA Drug recall D-0648-2022
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831…
- FDA Drug
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831… by Revive Rx, citing non-sterility; bacterial contamination identified as Paenibacillus lautus.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0648-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-02-11 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Revive Rx |
| Distribution | US |
Product
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Reason
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Identifiers
| code_info | Lot: 631359 BUD: 05/01/2022 |
|---|
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-0648-2022%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.