Drugplain

PHENTOLAMINE MESYLATE 5 mg/1

PHENTOLAMINE MESYLATE · INJECTION · Precision Dose Inc.

10 Recalls on Record
Plain English

PHENTOLAMINE MESYLATE is a injection containing phentolamine mesylate at 5 mg/1, taken intramuscular. Manufactured by Precision Dose Inc..

Key Facts

Brand Name
PHENTOLAMINE MESYLATE
Generic Name
PHENTOLAMINE MESYLATE
NDC Code (Product)
68094-101
Manufacturer
Precision Dose Inc.
Strength
5 mg/1
Dosage Form
INJECTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA207686
Marketing Start
07/15/2017

Recall History

10 Recalls on Record
Class II01/15/2020

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II12/30/2022

Northern VA Compounders PLLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated
Class II12/30/2022

Northern VA Compounders PLLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II12/30/2022

Northern VA Compounders PLLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II08/27/2014

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is PHENTOLAMINE MESYLATE used for?

PHENTOLAMINE MESYLATE contains PHENTOLAMINE MESYLATE. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is PHENTOLAMINE MESYLATE a controlled substance?

PHENTOLAMINE MESYLATE is not classified as a controlled substance by the DEA.

What is the generic name for PHENTOLAMINE MESYLATE?

The generic name for PHENTOLAMINE MESYLATE is PHENTOLAMINE MESYLATE. There are 3 other brand versions of PHENTOLAMINE MESYLATE.

What is the NDC code for PHENTOLAMINE MESYLATE 5 mg/1?

The NDC (National Drug Code) for PHENTOLAMINE MESYLATE 5 mg/1 is 68094-101, listed by Precision Dose Inc..

Product NDC

68094-101

Package NDC

68094-101-20

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

Data from openFDA · Public domain (CC0 1.0)