CLASS II Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Ipratropium Bromide and Albuterol Sulfate Inhalation recalled
Cardinal Healthcare is recalling Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per, mL, distributed nationwide in the US. The recall was initiated on 26 Jan 2022 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-0161-2024
- FDA event ID
- 89450
- Recalling firm
- Cardinal Healthcare, Dublin, OH
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Inhalers & Asthma Medication
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +699 days |
| 3 Jan 2024 | 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
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product as listed by the FDA
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which lots are affected?
Batch 21C56
Where was it sold?
Nationwide USA
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
41 other products · FDA event 89450This product is part of a recall event; the main page for the event is Enoxaparin Sodium Injection recalled by Cardinal Healthcare.
More recalls from Cardinal Healthcare
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Folic Acid Tablets, USP, 1MG recalled by Cardinal HealthcareFolic Acid | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Citalopram Tablets, USP, 20MG recalled by Cardinal HealthcareCitalopram | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Jardiance (empagliflozin tablets), 25 mg (3 blister cards with each) recalledJardiance | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
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 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 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Nephron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |