May 2023 FDA Recall Drug by Revive Rx Llc Dba Revive Rx Pharmacy
D-0771-2023 - Sub-potent Drug

This Class II drug recall was voluntarily initiated by Revive Rx Llc Dba Revive Rx Pharmacy on May 11, 2023 for the product Drug. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0771-2023

Reason for Recall
Sub-potent Drug
Initiated
05-11-2023
Reported
05-31-2023
Quantity
45 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92329
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.

Batch or Lot Expiration Information

Lot# Lot: 1643397 BUD: 10/16/2023