FDA recall D-0192-2023

Pharmacy Innovations · Class II · drug

Product

Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2022-12-22
Report date
2023-02-01
Termination date
2024-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Erie, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0192-2023