RecallRadar

FDA Drug recall D-0766-2020

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

On 2020-01-22 the FDA classified a Class II recall of QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 by Assurance Infusion, citing lack of sterility assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0766-2020
ClassificationClass II
Statusterminated
Initiated2019-12-20
Published2020-01-22
Last updated2026-09-13 11:52 UTC
CompanyAssurance Infusion
DistributionUS

Product

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

Reason

Lack of sterility assurance.

Identifiers

code_info
Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/202…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0766-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.