April 2024 FDA Recall Drug by Revive Rx Llc Dba Revive Rx Pharmacy
D-0511-2024 - Labeling

This Class I drug recall was voluntarily initiated by Revive Rx Llc Dba Revive Rx Pharmacy on April 20, 2024 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0511-2024

Reason for Recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Initiated
04-20-2024
Reported
06-05-2024
Quantity
751 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94550
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.
Ongoing
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64

Batch or Lot Expiration Information

Lot# : 748127, Exp 9/24/2024