Navigation Links
Altaire Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 9 lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution sold under several brands

AQUEBOGUE, N.Y., Sept. 6, 2013 /PRNewswire/ -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution,  30 mL, to the consumer level. There have been no reports of adverse effects to consumers so far.  However, due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.

A product whose preservative is not effective could lead to use of a contaminated product which could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection.  It has been confirmed by Altaire that all lots of product were sterile at the time of release, and that the preservative was effective when challenged against the USP Preservative Effectiveness Test.  It has also been confirmed by Altaire that its production facility is not the source of any reported contaminants.

The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and labeled as follows:

  • equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.;
  • Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.;
  • lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) -  Dist. by Target Corp.  

Only the lots listed below are affected, and the recall is limited to the product in the 30 mL size

  • Lot # 11440, expiration date  09/2013, labeled for CVS;
  • Lot # 11441, expiration date  09/2013, labeled for CVS;
  • Lot # 12042, expiration date 01/2014, labeled for Wal-Mart and CVS; 
  • Lot # 12103, expiration date 02/2015, labeled for Wal-Mart;
  • Lot # 12203, expiration date 05/2015, labeled for Wal-Mart and CVS; 
  • Lot # 12207, expiration date 05/2015, labeled for Wal-Mart;
  • Lot # 12293, expiration date 08/2015, labeled for Wal-Mart; 
  • Lot # 12352, expiration date 09/2015, labeled for Target and CVS;
  • Lot # 12356, expiration date 09/2015, labeled for Target and CVS. 

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box.  Lot numbers can be found printed horizontally on the side of the label and on the bottom flap of the box.   The lots listed above were distributed between February 2012 and April 2013.   The product was sold nationwide at retail stores.

Altaire Pharmaceuticals is initiating the recall as a precautionary measure.  Altaire takes its mission of consumer care and providing quality products very seriously.  The company has reformulated the product with an enhanced preservative system.  All lots of the product in the 30 mL size identified with lot numbers beginning with 13 (i.e. 13000) have been made with the enhanced preservative system. 

Altaire Pharmaceuticals is notifying its customers of the recall by phone and letters for further notification to their retail stores.  Consumers who have the product with any of the lot numbers listed above should stop use of the product immediately and return it to the place of purchase.  

Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


SOURCE Altaire Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
2. Provectus Pharmaceuticals, Inc.s Investor Presentation Now Available for On-demand Viewing at
3. Keryx Biopharmaceuticals, Inc. To Host Conference Call on First Quarter 2012 Financial Results
4. Keryx Biopharmaceuticals, Inc. Announces First Quarter 2012 Financial Results
5. Auxilium Pharmaceuticals, Inc. to Present At The BofAML 2012 Health Care Conference
6. Depomed Announces Receipt of $1 million Milestone Payment From Ironwood Pharmaceuticals, Inc.
7. Auxilium Pharmaceuticals, Inc. and FCB I LLC Announce the Issuance of Composition of Matter Patent Covering Testim
8. Auxilium Pharmaceuticals, Inc. Raises Revenue Guidance And Reduces Net Loss Guidance For 2012
9. Auxilium Pharmaceuticals, Inc. to Present at the Goldman Sachs Global Healthcare Conference 2012
10. Hybrid Fuels, Inc. Announces Name Change to Nouveau Life Pharmaceuticals, Inc.
11. Debiopharm and Ascepion Pharmaceuticals, Inc. Announce an Exclusive License Agreement for the Development and Commercialisation of the Dual-Targeting Kinase Inhibitor, ASP-08126 (Debio 1144), for the Treatment of Oncology Diseases
Post Your Comments:
(Date:11/24/2015)... Abaxis, Inc. (NasdaqGS: ABAX ), a ... the medical, research, and veterinary markets worldwide, announced today ... present at the 27 th Annual Piper Jaffray ... a.m. ET. The conference will be held at The ... City . Abaxis, Inc. is a ...
(Date:11/24/2015)... Nov. 24, 2015   Mast Therapeutics, Inc. ... molecular adhesion and sealant technology (MAST) platform to develop ... stroke, today announced that the Company,s Chief Executive Officer, ... Piper Jaffray 27 th Annual Healthcare Conference on ... the New York Palace hotel in New ...
(Date:11/24/2015)... Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) announced today that the ... at the Piper Jaffray 27 th Annual Healthcare Conference ... (5:30 a.m. Pacific Time), at The New York Palace Hotel ... . A replay of the presentation will be available ... website several minutes prior to the start of the webcast ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... There’s nothing better than giving the ... all levels can enjoy. , This year, gardens are popping up in the ... living needs. , Vita Gardens’ African Keyhole Garden Bed ($499) , Water conscious ...
(Date:11/24/2015)... ... 24, 2015 , ... Wireless Analytics, an award-winning provider of ... weekday support capability. The “all hours” offering was introduced to extend live ... to enhance after-hours support available in the US. , Available as one of ...
(Date:11/24/2015)... ... 2015 , ... Take the audience on a journey with TransFrame Cloud from Pixel ... of images without ever setting a single keyframe in Final Cut Pro X. Design smooth ... controls to change the angle and depth of field to create a unique viewing perspective. ...
(Date:11/24/2015)... ... November 24, 2015 , ... Tuesday, December 1, 2015 Push to Walk ... letters to its supporters as part of their A Little Push Goes a Long ... giving where people are asked to support charities and non-profits on the Tuesday following ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... United States has performed a prostate tissue ablation procedure using the company’s ... on October 9, 2015. , This Sonablate® procedure, the first commercial focused ultrasound ...
Breaking Medicine News(10 mins):