US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 21, 2015 (11 years ago)

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Nephron Pharmaceuticals Corp.
NDC code
0487-0201-03
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0010-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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