HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vi...
FDA Recall #D-0648-2022 — Class I — February 11, 2022
Product Description
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.
Recalling Firm
Revive Rx LLC dba Revive Rx Pharmacy — Houston, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
115 vials
Distribution
Nationwide in the US.
Code Information
Lot: 631359 BUD: 05/01/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated