FDA recall D-66462-001

Nephron Pharmaceuticals Corp. · Class II · drug

Product

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

Reason for recall

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-10-02
Report date: 2013-10-30
Termination date: 2015-08-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66462-001