Drugplain

Premier Value 70 mL/100mL

Isopropyl Alcohol · SWAB · Pharmacy Value Alliance, LLC

10 Recalls on Record
Plain English

Premier Value is a swab containing isopropyl alcohol at 70 mL/100mL, taken topical. Manufactured by Pharmacy Value Alliance, LLC.

Key Facts

Brand Name
Premier Value
Generic Name
Isopropyl Alcohol
NDC Code (Product)
68016-809
Manufacturer
Pharmacy Value Alliance, LLC
Strength
70 mL/100mL
Dosage Form
SWAB
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
01/01/2021

Recall History

10 Recalls on Record
Class III04/11/2014

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

Raritan Pharmaceuticals, Inc.

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

TerminatedVoluntary: Firm initiated
Class II07/17/2017

Vi-Jon, Inc.

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

TerminatedVoluntary: Firm initiated
Class II11/26/2013

Humco Holding Group, Inc

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

TerminatedVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class II04/07/2016

Akorn, Inc.

Presence of Particulate Matter

TerminatedVoluntary: Firm initiated
Class II12/28/2023

Seaway Pharma Inc.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

OngoingVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

Superpotent Drug: high out of specification assay results for the menthol ingredient.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

pain12,318 reports
fatigue12,166 reports
drug ineffective11,877 reports
off label use9,794 reports
rheumatoid arthritis9,141 reports
abdominal discomfort8,102 reports
rash8,064 reports
alopecia7,984 reports
infusion related reaction7,845 reports
headache7,766 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms

Dosage & Administration

Directions • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor. Do not swallow tablets whole. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Warnings

Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 15 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Frequently Asked Questions

What is Premier Value used for?

Premier Value contains Isopropyl Alcohol. It is a swab taken topical. Consult your doctor for specific uses.

Is Premier Value a controlled substance?

Premier Value is not classified as a controlled substance by the DEA.

What is the generic name for Premier Value?

The generic name for Premier Value is Isopropyl Alcohol. There are 12 other brand versions of Isopropyl Alcohol.

What is the NDC code for Premier Value 70 mL/100mL?

The NDC (National Drug Code) for Premier Value 70 mL/100mL is 68016-809, listed by Pharmacy Value Alliance, LLC.