Drugplain

TESTOSTERONE 30 mg/1.5mL

TESTOSTERONE · SOLUTION · Alembic Pharmaceuticals Inc.

10 Recalls on Record
Plain English

Testosterone is a prescription androgen medication applied to the skin that is used to treat low testosterone levels in men. This topical solution contains 30 mg of testosterone per 1.5 mL dose.

Key Facts

Brand Name
TESTOSTERONE
Generic Name
TESTOSTERONE
NDC Code (Product)
62332-488
Manufacturer
Alembic Pharmaceuticals Inc.
Strength
30 mg/1.5mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
ANDA212882
Drug Class
Androgen [EPC]
Marketing Start
12/08/2021

Recall History

10 Recalls on Record
Class II06/02/2015

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

TerminatedVoluntary: Firm initiated
Class II03/22/2018

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

TerminatedVoluntary: Firm initiated
Class II03/10/2015

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

TerminatedVoluntary: Firm initiated
Class III03/13/2019

Lupin Pharmaceuticals Inc.

Defective Container: Repetitive complaints received indicating pump not working.

TerminatedVoluntary: Firm initiated
Class II01/26/2026

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Presence of Foreign substance - potential presence of metal particulate matter

OngoingVoluntary: Firm initiated
Class II03/22/2018

Partell Specialty Pharmacy

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

TerminatedVoluntary: Firm initiated
Class II04/06/2020

The Medicine Shoppe Pharmacy

Lack of Processing Control

TerminatedVoluntary: Firm initiated
Class II11/17/2016

Tri-Coast Pharmacy

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II05/28/2013

Main Street Family Pharmacy, LLC

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

TerminatedVoluntary: Firm initiated
Class III07/26/2018

Right Value Drug Stores, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is TESTOSTERONE used for?

Testosterone is a prescription androgen medication applied to the skin that is used to treat low testosterone levels in men. This topical solution contains 30 mg of testosterone per 1.5 mL dose.

Is TESTOSTERONE a controlled substance?

Yes, TESTOSTERONE is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for TESTOSTERONE?

The generic name for TESTOSTERONE is TESTOSTERONE. There are 12 other brand versions of TESTOSTERONE.

What is the NDC code for TESTOSTERONE 30 mg/1.5mL?

The NDC (National Drug Code) for TESTOSTERONE 30 mg/1.5mL is 62332-488, listed by Alembic Pharmaceuticals Inc..