FDA recall D-0648-2022

Revive Rx LLC dba Revive Rx Pharmacy · Class I · drug

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 for recall

Non-sterility; bacterial contamination identified as Paenibacillus lautus.

Distribution

Nationwide in the US.

Key facts

Status: Terminated
Initiation date: 2022-02-11
Report date: 2022-02-23
Termination date: 2024-08-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2022