FDA releases two eye and vision care-related advisoriesOctober 9, 2013
The U.S. Food and Drug Administration (FDA) recently issued the following public advisories related to eye and vision care.
Altaire voluntarily recalls 9 ophthalmic solution lots
Altaire Pharmaceuticals, Inc. issued a voluntary nationwide recall of nine lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, sold under several brands, because the preservative may not be effective through the expiration date.
The FDA alert for the voluntary recall is available at http://tinyurl.com/ FDAAltaire.
NuVision Pharmacy sterile products
The FDA is again cautioning health care practitioners against the use of sterile products from NuVision Pharmacy. The Texas-based compounding pharmacy has refused to comply with a July 26, 2013, FDA request to recall its entire line of sterile products. The FDA found evidence of poor sterile production practices during an April 2013 inspection at NuVision’s Dallas facilities and issued an initial alert to health practitioners May 18, 2013.
Following the April inspection, NuVision recalled its methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and quality control concerns.
The inspection was prompted by reports to the FDA regarding adverse events associated with the methylcobalamin product.
The agency is not aware of any adverse event reports associated with other sterile products from NuVision.
The FDA notes that if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections.
The FDA advisory is available at http://tinyurl.com/FDANuVision.
More FDA alerts are available at www.aoa.org/FDAalerts.