Drugplain

Ipratropium Bromide 21 ug/1

Ipratropium Bromide · SPRAY, METERED · Apotex Corp.

7 Recalls on Record
Plain English

Ipratropium Bromide is a spray, metered containing ipratropium bromide at 21 ug/1, taken nasal. Manufactured by Apotex Corp..

Key Facts

Brand Name
Ipratropium Bromide
Generic Name
Ipratropium Bromide
NDC Code (Product)
60505-0826
Manufacturer
Apotex Corp.
Strength
21 ug/1
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
ANDA076156
Marketing Start
05/26/2020

Recall History

7 Recalls on Record
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II08/28/2012

Dispensing Solutions, Inc

Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol

TerminatedVoluntary: Firm initiated
Class II03/26/2024

Cipla USA, Inc.

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

TerminatedVoluntary: Firm initiated
Class II08/21/2015

Nephron Pharmaceuticals Corp.

Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process

TerminatedVoluntary: Firm initiated
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated
Class II07/24/2015

Boehringer Ingelheim Roxane Inc

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

TerminatedVoluntary: Firm initiated
Class III04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,886 reports
pneumonia1,053 reports
drug ineffective1,003 reports
cough899 reports
fatigue860 reports
nausea818 reports
off label use745 reports
headache686 reports
diarrhoea672 reports
asthma633 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is Ipratropium Bromide used for?

Ipratropium Bromide contains Ipratropium Bromide. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is Ipratropium Bromide a controlled substance?

Ipratropium Bromide is not classified as a controlled substance by the DEA.

What is the generic name for Ipratropium Bromide?

The generic name for Ipratropium Bromide is Ipratropium Bromide. There are 5 other brand versions of Ipratropium Bromide.

What is the NDC code for Ipratropium Bromide 21 ug/1?

The NDC (National Drug Code) for Ipratropium Bromide 21 ug/1 is 60505-0826, listed by Apotex Corp..