Drugplain

Cetirizine Hydrochloride Oral Solution 5 mg/5mL

Cetirizine Hydrochloride Oral Solution · SOLUTION · Chartwell RX, LLC

6 Recalls on Record
Plain English

Cetirizine Hydrochloride Oral Solution is a solution containing cetirizine hydrochloride oral solution at 5 mg/5mL, taken oral. Manufactured by Chartwell RX, LLC.

Key Facts

Brand Name
Cetirizine Hydrochloride Oral Solution
Generic Name
Cetirizine Hydrochloride Oral Solution
NDC Code (Product)
62135-057
Manufacturer
Chartwell RX, LLC
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA078876
Marketing Start
05/11/2012

Recall History

6 Recalls on Record
Class II10/19/2018

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II10/19/2018

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

TerminatedVoluntary: Firm initiated
Class II10/19/2018

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class III12/16/2013

Qualitest Pharmaceuticals

Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

accidental overdose1 reports
bicuspid aortic valve1 reports
bradycardia1 reports
drug abuse1 reports
drug interaction1 reports
hypotension1 reports
lung abscess1 reports
muscular weakness1 reports
pancreatitis chronic1 reports
pneumonia1 reports

Frequently Asked Questions

What is Cetirizine Hydrochloride Oral Solution used for?

Cetirizine Hydrochloride Oral Solution contains Cetirizine Hydrochloride Oral Solution. It is a solution taken oral. Consult your doctor for specific uses.

Is Cetirizine Hydrochloride Oral Solution a controlled substance?

Cetirizine Hydrochloride Oral Solution is not classified as a controlled substance by the DEA.

What is the generic name for Cetirizine Hydrochloride Oral Solution?

The generic name for Cetirizine Hydrochloride Oral Solution is Cetirizine Hydrochloride Oral Solution. There are no other listed brand versions of Cetirizine Hydrochloride Oral Solution.

What is the NDC code for Cetirizine Hydrochloride Oral Solution 5 mg/5mL?

The NDC (National Drug Code) for Cetirizine Hydrochloride Oral Solution 5 mg/5mL is 62135-057, listed by Chartwell RX, LLC.

Product NDC

62135-057

Package NDC

62135-057-41

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)