FDA recall D-0711-2021

Med Shop Total Care Inc. · Class I · drug

Product

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Reason for recall

Non-Sterility

Distribution

Texas and Puerto Rico

Key facts

Status
Terminated
Initiation date
2020-10-05
Report date
2021-08-18
Termination date
2023-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Longview, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0711-2021