Polyvinyl Alcohol 14 mg/mL
Polyvinyl Alcohol · SOLUTION/ DROPS · AvPAK
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
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cardinal Health Inc.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Kilitch Healthcare India Limited
Non-Sterility
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
Kilitch Healthcare India Limited
Non-Sterility
Kilitch Healthcare India Limited
Non-Sterility
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.
Kilitch Healthcare India Limited
Non-Sterility
BRS Analytical Services, LLC
cGMP deviations and lack of assurance of sterility.
Akorn, Inc.
CGMP Deviations:
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)