CLASS II Drug recall · Reported 15 Aug 2012 · FDA Enforcement Report
Albuterol Sulfate Inhalation Solution recalled
Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/ Sterile Unit-Dose Vials ( mL, distributed nationwide in the US. The recall was initiated on 22 Jun 2011 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-1446-2012
- FDA event ID
- 62604
- Recalling firm
- Nephron Pharmaceuticals, Orlando, FL
- Brand
- Albuterol Sulfate
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2011
- FDA classified
- 9 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Inhalers & Asthma Medication
Timeline
| 22 Jun 2011 | Recall initiated by company | |
| 9 Aug 2012 | Classified by FDA | +414 days |
| 15 Aug 2012 | Published in enforcement report | +6 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
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
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Where was it sold?
Nationwide and Puerto Rico
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.
More recalls from Nephron Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg recalled | Nephron Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | del Nido Cardioplegia Solution, Single-Dose Container recalled | Nephron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl recalled | Nephron Pharmaceuticals | Foreign Material | Nationwide |
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Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | Nationwide |
| Drug | CLASS III | Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra | AsttraZeneca Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |