FDA Drug Recalls

Recalls / Class II

Class IID-0752-2020

Product

MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Affected lot / code info
Lot: 12112019@19 Exp. 12/20/2019

Why it was recalled

Lack of sterility assurance.

Recalling firm

Firm
Assurance Infusion
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2626 S Loop W Ste 555, Houston, Texas 77054-2652

Distribution

Quantity
1 syringe
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2019-12-20
FDA classified
2020-01-13
Posted by FDA
2020-01-22
Terminated
2021-10-27
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0752-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.