CLASS II Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalled
Nephron Pharmaceuticals is recalling Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0010-2016
- FDA event ID
- 72099
- Recalling firm
- Nephron Pharmaceuticals, Orlando, FL
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2015
- FDA classified
- 9 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Inhalers & Asthma Medication
Timeline
| 21 Aug 2015 | Recall initiated by company | |
| 9 Oct 2015 | Classified by FDA | +49 days |
| 21 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Which lots are affected?
a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ipratropium recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate | Cipla USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg recalledIpratropium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |