CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
Albuterol 1.25mg / Ipratropium 0.5mg Vial recalled
Integrated Health Concepts is recalling Albuterol 1.25mg / Ipratropium 0.5mg Vial, For Inhalation Only, Conversio Health, San, distributed nationwide in the US. The recall was initiated on 12 Nov 2019 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-0515-2020
- FDA event ID
- 84284
- Recalling firm
- Integrated Health Concepts, San Luis Obispo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2019
- FDA classified
- 19 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 12 Nov 2019 | Recall initiated by company | |
| 19 Nov 2019 | Classified by FDA | +7 days |
| 27 Nov 2019 | Published in enforcement report | +8 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 Processing Controls
Product as listed by the FDA
Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Lack of Processing Controls
Which lots are affected?
All lots
Where was it sold?
Nationwide in the U.S.
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.
Other products in this recall event
9 other products · FDA event 84284This product is part of a recall event; the main page for the event is Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 2.5mg / Ipratropium 0.75mg Vial recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg Vial recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Budesonide 0.4mg Vial, For Inhalation Only recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Formoterol 12mcg / Budesonide 0.5mg Vial recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 3.75mg / Ipratropium 0.75mg Vial recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 2.5mg / Budesonide 0.5mg Vial recalled | Integrated Health Concepts | Other | Nationwide | |
| CLASS II | Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg recalled | Integrated Health Concepts | Other | Nationwide |
More recalls from Integrated Health Concepts
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg recalled | Integrated Health Concepts | Other | Nationwide |
| Drug | CLASS II | Albuterol 2.5mg / Budesonide 0.5mg Vial recalled | Integrated Health Concepts | Other | Nationwide |
| Drug | CLASS II | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg recalled | Integrated Health Concepts | Other | Nationwide |
| Drug | CLASS II | Albuterol 3.75mg / Ipratropium 0.75mg Vial recalled | Integrated Health Concepts | Other | Nationwide |
| Drug | CLASS II | Formoterol 12mcg / Budesonide 0.5mg Vial recalled | Integrated Health Concepts | Other | Nationwide |
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 |