February 2022 FDA Recall Drug by Revive Rx Llc Dba Revive Rx Pharmacy
D-0648-2022 - Non-sterility; bacterial contamination identified as Paenibacillus lautus.

This Class I drug recall was voluntarily initiated by Revive Rx Llc Dba Revive Rx Pharmacy on February 11, 2022 for the product Drug. The FDA reported the reason for recall as non-sterility; bacterial contamination identified as paenibacillus lautus.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0648-2022

Reason for Recall
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Initiated
02-11-2022
Reported
02-23-2022
Quantity
115 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89591
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Revive Rx LLC dba Revive Rx Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-23-2024
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot: 631359 BUD: 05/01/2022