Recall: D-0010-2016

Class II - Potentially Harmful

Class IIClassification

2015-08-21Initiated

TerminatedStatus

Nephron Pharmaceuticals Corp.Firm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.