Mold and fungus can be hazardous to the health of consumers, especially if they are found in a product that is meant to be consumed. While mold can be expected to grow on certain perishable foods such as bread and fruit, it might come as a surprise to find mold or detect fungus in pharmaceutical products. In March, Med Prep Consulting Inc. voluntarily recalled a magnesium sulfate IV solution due to the presence of fungus in at least five bags.
Sometimes, an ineffective preservative can lead to the growth of mold. Altaire Pharmaceuticals is currently recalling nine lots of eye drops, carboxymethylcellulose sodium 0.5% opthalmic solution, due to concerns that their preservative may not last through the expiration date.
According to a press release released on the Food & Drug Administration’s website, mold has been found in the solutions after use, indicating the preservative might not have been as effective as it was intended to be. The recall is prompted by “concerns regarding the effectiveness of the preservative after use and handling of the product by consumers,” according to the press release. To date, no adverse events to consumers due to the issue have been reported.
The recalled eye drops are known as a generic formulation of carboxymethylcellulose sodium 0.5% opthalmic solution and were labeled as three different brands. The labels are:
● “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.”
The recall affects only the 30 mL products, and the nine lot numbers are listed on the FDA’s website. The affected eye drops, which were distributed between February 2012 and April 2013, have the lot numbers printed horizontally on the side of the label and on the bottom flap of the box.
Altaire Pharmaceuticals states that it will notify consumers about the recall by phone and letter. The company urges consumers to stop using the product and return it to the retailer of purchase. Consumers can contact the company at 800-258-2471 weekdays from 9 a.m. to 5 p.m. ET for more information.