Altaire recalls moldy eye solution made for Walmart, CVS, Target

Altaire Pharmaceuticals recalled 9 lots of ophthalmic solution sold under Walmart, CVS and Target brands after receiving complaints of mold found in its 30 mL bottles once they were opened. The Aqueboque, NY, company said that the preservative used in the product may not be effective, allowing contamination which could result in eye infections. According to Altaire, there have not been any reported adverse events tied to the carboxymethylcellulose sodium 0.5% ophthalmic solution, but it is voluntarily recalling the bottles as a precaution. The company has reformulated the product with an enhanced preservative system, and all lots in the 30 mL size that have a lot number beginning with 13 (i.e. 13000) have been manufactured with the enhanced preservative, it said. In 2011, Altaire received a warning letter from the FDA for manufacturing a sterile ophthalmic solution and a variety of solutions of fluorescein injection that the FDA said qualified as prescription drugs but for which the company had not gotten FDA approval. Release | Warning letter