Drugplain

ISOPROTERENOL .2 mg/mL

isoproterenol hydrochloride · INJECTION, SOLUTION · Cipla USA Inc.

5 Recalls on Record
Plain English

ISOPROTERENOL is a injection, solution containing isoproterenol hydrochloride at .2 mg/mL, taken intracardiac. Manufactured by Cipla USA Inc..

Key Facts

Brand Name
ISOPROTERENOL
Generic Name
isoproterenol hydrochloride
NDC Code (Product)
69097-521
Manufacturer
Cipla USA Inc.
Strength
.2 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #
ANDA210322
Marketing Start
06/26/2018

Recall History

5 Recalls on Record
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/18/2019

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II06/18/2019

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II06/18/2019

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is ISOPROTERENOL used for?

ISOPROTERENOL contains isoproterenol hydrochloride. It is a injection, solution taken intracardiac. Consult your doctor for specific uses.

Is ISOPROTERENOL a controlled substance?

ISOPROTERENOL is not classified as a controlled substance by the DEA.

What is the generic name for ISOPROTERENOL?

The generic name for ISOPROTERENOL is isoproterenol hydrochloride. There are 11 other brand versions of isoproterenol hydrochloride.

What is the NDC code for ISOPROTERENOL .2 mg/mL?

The NDC (National Drug Code) for ISOPROTERENOL .2 mg/mL is 69097-521, listed by Cipla USA Inc..