FDA recall D-0010-2016

Product

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL

Reason for recall

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-21

Report date

2015-10-21

Termination date

2017-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2016