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Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug...

FDA Recall #D-0771-2023 — Class II — May 11, 2023

Recall #D-0771-2023 Date: May 11, 2023 Classification: Class II Status: Ongoing

Product Description

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.

Reason for Recall

Sub-potent Drug

Recalling Firm

Revive Rx LLC dba Revive Rx Pharmacy — Houston, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

45 Vials

Distribution

Nationwide in the US

Code Information

Lot: 1643397 BUD: 10/16/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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