Drugplain

carboxymethylcellulose sodium 5 mg/mL

carboxymethylcellulose sodium · SOLUTION/ DROPS · AvPAK

10 Recalls on Record
Plain English

carboxymethylcellulose sodium is a solution/ drops containing carboxymethylcellulose sodium at 5 mg/mL, taken ophthalmic. Manufactured by AvPAK.

Key Facts

Brand Name
carboxymethylcellulose sodium
Generic Name
carboxymethylcellulose sodium
NDC Code (Product)
50268-068
Manufacturer
AvPAK
Strength
5 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
11/19/2020

Recall History

10 Recalls on Record
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class I01/30/2023

Global Pharma Healthcare Private Limited

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

OngoingVoluntary: Firm initiated
Class I01/30/2023

Global Pharma Healthcare Private Limited

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

OngoingVoluntary: Firm initiated
Class III12/18/2024

AvKARE

LABELING: LABEL MIX-UP

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 II04/03/2017

Cell Distributors

Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.

TerminatedVoluntary: Firm initiated
Class I11/13/2023

Kilitch Healthcare India Limited

Non-Sterility

OngoingVoluntary: Firm initiated
Class I09/06/2013

Altaire Pharmaceuticals, Inc.

Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.

TerminatedVoluntary: Firm initiated
Class II04/23/2025

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective382 reports
macular degeneration351 reports
nausea249 reports
off label use240 reports
weight decreased198 reports
pain197 reports
pyrexia181 reports
malaise178 reports
infusion related reaction177 reports
therapeutic product effect incomplete171 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.

Dosage & Administration

Directions To open, TWIST AND PULL TAB TO REMOVE . Instill 1 or 2 drops in the affected eye(s) as needed and discard container. Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

Warnings

Warnings For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard. Do not touch unit-dose tip to eye. Do not use If solution changes color or becomes cloudy. 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 reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is carboxymethylcellulose sodium used for?

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

Is carboxymethylcellulose sodium a controlled substance?

carboxymethylcellulose sodium is not classified as a controlled substance by the DEA.

What is the generic name for carboxymethylcellulose sodium?

The generic name for carboxymethylcellulose sodium is carboxymethylcellulose sodium. There are 11 other brand versions of carboxymethylcellulose sodium.

What is the NDC code for carboxymethylcellulose sodium 5 mg/mL?

The NDC (National Drug Code) for carboxymethylcellulose sodium 5 mg/mL is 50268-068, listed by AvPAK.