BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (7...

FDA Recall #D-0689-2020 — Class II — December 20, 2019

Recall #D-0689-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ 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

2 syringe

Distribution

Nationwide within the United States

Code Information

Lot: 12122019@4 Exp. 12/21/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated