FDA recall D-1850-2019

Pacifico National, Inc. dba AmEx Pharmacy · Class II · drug

Product

Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Reason for recall

Lack of assurance of sterility.

Distribution

Continental U.S. and Puerto Rico

Key facts

Status
Terminated
Initiation date
2019-08-30
Report date
2019-09-18
Termination date
2020-10-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Melbourne, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1850-2019