BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533...
FDA Recall #D-0673-2020 — Class II — December 20, 2019
Product Description
BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/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
1 syringe
Distribution
Nationwide within the United States
Code Information
Lot: 12202019@2 Exp. 12/20/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated