Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution Recalled by Nephron Pharmaceuticals Corp. Due to Lack of Assurance of Sterility; potential exposure to...

Date: August 21, 2015
Company: Nephron Pharmaceuticals Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nephron Pharmaceuticals Corp. directly.

Affected Products

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

Quantity: a) 85,248 cartons and b) 35,292 cartons

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nephron Pharmaceuticals Corp.

Nephron Pharmaceuticals Corp. has 10 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report