Skip to content
Recall Observatory FDA recall evidence

Drug product

MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0755-2020

December 20, 2019

Class II

Product summary

Firm
Assurance Infusion
Event
Event 84546
Status
Terminated
Classification
Class II
Quantity
3 syringes
Official record key
drug-enforcement:D-0755-2020

Official wording

Reason: Lack of sterility assurance.

Code information: Lot: 12102019@7 Exp. 12/19/2019; 12112019@11 Exp. 12/20/2019; 12162019@5 Exp. 12/25/2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility