Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

FDA Recall #D-0677-2020 — Class II — December 20, 2019

Recall #D-0677-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials 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

15 vials

Distribution

Nationwide within the United States

Code Information

Lots: 09192019@19 Exp. 03/17/2020; 08162019@5 Exp. 02/12/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated