Recall archive / FDA company announcement
Cipla: Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) — FDA announcement Jul 7, 2023
Reported terminated
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jul 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)
- Reason
- Failure to deliver the recommended dose
- Classification
- Not supplied
- Recalling firm
- Cipla
- Quantity
- Not supplied
- Agency-reported status
- Terminated in FDA listing
- Source record identifier
- d70c8614d54531f4
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled.; Sr. No. | Product Name | Batch No. | Expiry Date; 1. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20045 | Nov.2023; 2. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20055 | Nov.2023; 3. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20056 | Nov.2023; 4. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20057 | Nov.2023; 5. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20059 | Nov.2023; 6. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20072 | Nov.2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| Sr. No. | Product Name | Batch No. | Expiry Date |
|---|---|---|---|
| 1. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20045 | Nov.2023 |
| 2. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20055 | Nov.2023 |
| 3. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20056 | Nov.2023 |
| 4. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20057 | Nov.2023 |
| 5. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20059 | Nov.2023 |
| 6. | Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) | IB20072 | Nov.2023 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60. These 6 batches were distributed Nationwide to wholesalers and retailers.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Jul 7, 2023
- Company announcement date
- Jul 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.