D-0749-2020 Class II Terminated

Recalled by Assurance Infusion — Houston, TX

FDA drug recall D-0749-2020 was initiated by Assurance Infusion on December 20, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated October 27, 2021). Affected quantity: 2 syringes/1 vial.

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
2 syringes/1 vial

Product Description

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide within the United States

Code Information

Lot: 09172019@18 Exp. 03/15/2020