FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
FDA Recall #D-0728-2020 — Class II — December 20, 2019
Product Description
FENTANYL 3000MCG/ML 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
Lots: 12122019@18 Exp. 12/21/2019; 12162019@24 Exp. 12/25/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated