Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP recall
FDA recall D-0471-2024 · initiated Mar 26, 2024
Cipla USA, Inc. recalled Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP in Mar 2024 — an FDA Class II recall (D-0471-2024) because Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 59244/3ml FFS packs
Details
- Product
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Mar 26, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP recalled?
- Cipla USA, Inc. recalled Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP in Mar 2024 — an FDA Class II recall (D-0471-2024) because Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP recalled?
- Per the FDA enforcement record, the reason for recall D-0471-2024 was: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- Is a recalled Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0471-2024.