TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

FDA Recall #D-0779-2020 — Class II — December 20, 2019

Recall #D-0779-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Reason for Recall

Lack of sterility assurance.

Recalling Firm

Assurance Infusion — Houston, TX

Classification

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

Product Type

Drugs

Product Quantity

45 vials

Distribution

Nationwide within the United States

Code Information

Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated