HCG 6 recalled over sterility concerns

Recall date

February 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Revive Rx LLC dba Revive Rx Pharmacy recalls HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounde…

Recall number

D-0648-2022

FDA classification

Class I

Brand / firm

Revive Rx LLC dba Revive Rx Pharmacy

Sold / distributed

Nationwide in the US.

Why it was recalled

Non-sterility; bacterial contamination identified as Paenibacillus lautus.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.