A recall of the popular drug, Albuterol Sulfate, has been issued due to a defect in the inhaler valve that causes the medication to leak rather than be delivered to the patient. This could be deadly for those who use these “rescue inhalers” for Asthma, Chronic Obstructive Pulmonary Disease (COPD), or symptoms such as shortness of breath due to infection. As of the writing of this notice, no adverse effects have yet been reported. However, patients using this medication should immediately obtain a replacement if their inhaler is listed in the recall (see below).
SUMMARY
Date of Recall:
Announced: July 6, 2023
Public Notification: July 7, 2023
Name(s) of Drug:
Albuterol Sulfate, 90mcg
Company Name:
Cipla
Drug Indication:
Asthma
COPD
Shortness of Breath
Product Description
The product is distributed in aluminum containers that hold 17ml of medication. Each container comes with a dose counter, plastic actuator, and dust cap. They are packed within a cardboard box that indicates the name of the medication, dosage, etc.
Image sourced from: https://www.ciplaalbuterolhfa.com/HCP/index.html
Reason for Recall
While no adverse reactions have been reported yet, the device used to deliver the medication is faulty. It can result in patients not receiving emergency medication when needed.
Impacts
Consumers who continue to utilize the faulty actuator may find that their asthma, COPD, or other respiratory symptoms worsen, which could lead to respiratory failure (an inability to breathe) and death.
Lot Information
Locate the box in which the medication came or the aluminum bottle containing the drug. Compare with product name, batch number, and expiration dates below. If your prescription is included in the recall, see below for further information on obtaining a replacement and disposing of the recalled product.
| Product Description | Batch Number | Expiration Date |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20045 | Nov. 2023 |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20055 | Nov. 2023 |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20056 | Nov. 2023 |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20057 | Nov. 2023 |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20059 | Nov. 2023 |
| Abluterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20072 | Nov. 2023 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
NOTE: CONSUMERS SHOULD NOT DISCONTINUE THIS MEDICATION ABRUPTLY.
SPEAK TO YOUR DOCTOR BEFORE MAKING ANY CHANGES.
If you find that your lot of medication is part of this recall, do the following:
- Call your doctor immediately. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
- Consumers may contact Cipla Customer Service at 1-844-247-5287. They are available Mon-Fri from 8:30 am to 5:00 pm (EST). You can also contact them via email at cipla.cs@cipla.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Cipla Customer Service at 1-844-247-5287 or via email at cipla.cs@cipla.com. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Cipla Customer Service at 1-844-247-5287 or email them at cipla.cs@cipla.com. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn.