FDA recall D-0801-2018

Coast Quality Pharmacy LLC · Class II · drug

Product

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

Reason for recall

Lack of Assurance of Sterility

Distribution

AL, CA, FL, MI, SC, TX

Key facts

Status: Terminated
Initiation date: 2018-04-26
Report date: 2018-05-16
Termination date: 2020-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2018