Artificial Tears 1 mg/mL
Artificial Tears · SOLUTION/ DROPS · AvPAK
Artificial Tears is a solution/ drops containing artificial tears at 1 mg/mL, taken ophthalmic. Manufactured by AvPAK.
Key Facts
- Brand Name
- Artificial Tears
- Generic Name
- Artificial Tears
- NDC Code (Product)
50268-043- Manufacturer
- AvPAK
- Strength
- 1 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- M018
- Drug Class
- Plasma Volume Expander [EPC]; Non-Standardized Chemical Allergen [EPC]
- Marketing Start
- 01/05/2023
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
K.C. Pharmaceuticals, Inc
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
BRS Analytical Services, LLC
cGMP deviations and lack of assurance of sterility.
Global Pharma Healthcare Private Limited
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
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 or 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 lens 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 Artificial Tears used for?
Artificial Tears contains Artificial Tears. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Artificial Tears a controlled substance?
Artificial Tears is not classified as a controlled substance by the DEA.
What is the generic name for Artificial Tears?
The generic name for Artificial Tears is Artificial Tears. There are no other listed brand versions of Artificial Tears.
What is the NDC code for Artificial Tears 1 mg/mL?
The NDC (National Drug Code) for Artificial Tears 1 mg/mL is 50268-043, listed by AvPAK.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)