Ipratropium Bromide 0 recalled over sterility concerns

Recall date

August 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nephron Pharmaceuticals Corp. recalls Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials,…

Recall number

D-0010-2016

FDA classification

Class II

Brand / firm

Nephron Pharmaceuticals Corp.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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