Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the fo...

FDA Drug Recall #D-375-2014 — Class I — September 6, 2013

Recall Summary

Recall Number D-375-2014
Classification Class I — Serious risk
Date Initiated September 6, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Altaire Pharmaceuticals, Inc.
Location Aquebogue, NY
Product Type Drugs
Quantity 363,746 bottles.

Product Description

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.

Reason for Recall

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.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.

Other Recalls from Altaire Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0394-2020 Class II CVS Health Redness Relief Lubricant Redness Rel... Jul 2, 2019
D-0403-2020 Class II CVS Health Fast Acting Lubricant Eye Drops Dry ... Jul 2, 2019
D-0369-2020 Class II Equate Support Advanced Twin Pack W-M item #: ... Jul 2, 2019
D-0396-2020 Class II CVS Health Lubricant Eye Drops Multi-Symptom Ey... Jul 2, 2019
D-0375-2020 Class II CVS Health Lubricant Eye Drops for Mild to Mod... Jul 2, 2019

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.