Medications & Supplements/Prescription Drugs

Cipla Albuterol Inhalers Recalled Due to Container Defects and Leakage

Agency Publication Date: July 12, 2023

Summary

Cipla USA, Inc. is recalling 278,538 canisters of Albuterol Sulfate Inhalation Aerosol (90 mcg), a generic rescue medication used to treat breathing difficulties. The recall was issued because a defective container gasket can lead to leaking medication or a completely empty inhaler. While no injuries have been reported, consumers should verify their inhalers against the affected lot numbers to ensure they have working medication available for respiratory emergencies.

Risk

A missing or damaged gasket in the inhaler valve causes the medication to leak out, which can leave the device empty or unable to deliver the required dose during an asthma attack or other breathing emergency.

What You Should Do

This recall affects Albuterol Sulfate Inhalation Aerosol (90 mcg, 200 Metered Inhalation) sold in 6.7 g canisters packaged in a box (NDC 69097-142-60).
Check the box or the inhaler canister for the following lot numbers: IB20045, IB20055, IB20056, IB20057, IB20059, or IB20072. All affected lots have an expiration date of November 30, 2023.
If you have health concerns regarding your medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla USA, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions or to report adverse events.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Albuterol Sulfate Inhalation Aerosol (6.7 g canister)by Cipla

Variants: 90 mcg, 200 Metered Inhalations, Rx Only

Lot Numbers:

IB20045 (Exp Nov. 30, 2023)

IB20055 (Exp Nov. 30, 2023)

IB20056 (Exp Nov. 30, 2023)

IB20057 (Exp Nov. 30, 2023)

IB20059 (Exp Nov. 30, 2023)

IB20072 (Exp Nov. 30, 2023)

NDC:

69097-142-60

Manufactured by Cipla Ltd, Pithampur, India; Distributed by Cipla USA, Inc. Warren, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92616

Status: Resolved

Manufacturer: Cipla USA, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 278,538 canisters

Distributed To: Nationwide

Agency Last Updated: July 21, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Albuterol Sulfate Inhalation Aerosol (90 mcg, 200 Metered Inhalation) sold in 6.7 g canisters packaged in a box (NDC 69097-142-60).

Check the box or the inhaler canister for the following lot numbers: IB20045, IB20055, IB20056, IB20057, IB20059, or IB20072. All affected lots have an expiration date of November 30, 2023.

If you have health concerns regarding your medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla USA, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions or to report adverse events.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Albuterol Sulfate Inhalation Aerosol (6.7 g canister)by Cipla

Variants: 90 mcg, 200 Metered Inhalations, Rx Only

Lot Numbers:

IB20045 (Exp Nov. 30, 2023)

IB20055 (Exp Nov. 30, 2023)

IB20056 (Exp Nov. 30, 2023)

IB20057 (Exp Nov. 30, 2023)

IB20059 (Exp Nov. 30, 2023)

IB20072 (Exp Nov. 30, 2023)

NDC:

69097-142-60

Manufactured by Cipla Ltd, Pithampur, India; Distributed by Cipla USA, Inc. Warren, NJ.