LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion ...

FDA Recall #D-0749-2020 — Class II — December 20, 2019

Recall #D-0749-2020 Date: December 20, 2019 Classification: Class II Status: Terminated

Product Description

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 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

2 syringes/1 vial

Distribution

Nationwide within the United States

Code Information

Lot: 09172019@18 Exp. 03/15/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated