Drugplain

Polyvinyl Alcohol 14 mg/mL

Polyvinyl Alcohol · SOLUTION/ DROPS · AvPAK

10 Recalls on Record
Plain English

Polyvinyl Alcohol is a solution/ drops containing polyvinyl alcohol at 14 mg/mL, taken ophthalmic. Manufactured by AvPAK.

Key Facts

Brand Name
Polyvinyl Alcohol
Generic Name
Polyvinyl Alcohol
NDC Code (Product)
50268-678
Manufacturer
AvPAK
Strength
14 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
01/05/2023

Recall History

10 Recalls on Record
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class I10/31/2023

Cardinal Health Inc.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

OngoingVoluntary: Firm initiated
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class I10/31/2023

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

TerminatedVoluntary: Firm initiated
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class II04/23/2025

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

OngoingVoluntary: Firm initiated
Class II10/13/2022

Akorn, Inc.

CGMP Deviations:

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea32 reports
dyspnoea27 reports
hypotension25 reports
diarrhoea24 reports
dizziness24 reports
fatigue24 reports
off label use22 reports
acute kidney injury20 reports
death20 reports
pyrexia18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Dosage & Administration

Directions instill 1 to 2 drops in the affected eye(s) as needed

Warnings

Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Frequently Asked Questions

What is Polyvinyl Alcohol used for?

Polyvinyl Alcohol contains Polyvinyl Alcohol. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Polyvinyl Alcohol a controlled substance?

Polyvinyl Alcohol is not classified as a controlled substance by the DEA.

What is the generic name for Polyvinyl Alcohol?

The generic name for Polyvinyl Alcohol is Polyvinyl Alcohol. There are 11 other brand versions of Polyvinyl Alcohol.

What is the NDC code for Polyvinyl Alcohol 14 mg/mL?

The NDC (National Drug Code) for Polyvinyl Alcohol 14 mg/mL is 50268-678, listed by AvPAK.