BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

FDA Recall #D-0690-2020 — Class II — December 20, 2019

Recall #D-0690-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe 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

1 syringe

Distribution

Nationwide within the United States

Code Information

Lot: 12102019@3 Exp. 12/19/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated