Home / Recalls / Assurance Infusion / D-0766-2020

D-0766-2020 Class II Terminated

Recalled by Assurance Infusion — Houston, TX

Recall Details

Product Type
Drugs
Report Date
January 22, 2020
Initiation Date
December 20, 2019
Termination Date
October 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
134 vials

Product Description

QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide within the United States

Code Information

Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/2020; 11272019@24 Exp. 01/22/2020; 09182019@18 Exp. 03/16/2020

Other recalls by Assurance Infusion

  • D-0673-2020 Class II — BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance I (December 20, 2019)
  • D-0777-2020 Class II — TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) (December 20, 2019)
  • D-0733-2020 Class II — FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 (December 20, 2019)
  • D-0736-2020 Class II — HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 (December 20, 2019)
  • D-0744-2020 Class II — HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 (December 20, 2019)
  • D-0702-2020 Class II — BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusio (December 20, 2019)
  • D-0719-2020 Class II — BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (71 (December 20, 2019)
  • D-0696-2020 Class II — BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713 (December 20, 2019)
  • D-0743-2020 Class II — HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 (December 20, 2019)
  • D-0674-2020 Class II — BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8 (December 20, 2019)