The U.S. Food and Drug Administration this week issued a warning advising consumers and eyecare professionals to discontinue the use of Deslam Pharma’s Artificial Eye Ointment.
FDA officials cited concerns of a possible bacteria contamination. The agency noted the connection with a warning earlier this month against the use of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
All three products are produced by Indian pharmaceutical company Global Pharma Healthcare Private Limited. All three are sold over the counter.
On Feb. 1, the Centers for Disease Control and Prevention announced a nationwide health alert. The CDC said it was investigating a disturbing rise in Pseudomonas aeruginosa infections across multiple states. Early discoveries led investigators to signal out Global Pharma Healthcare’s artificial tears products as potential sources. There have been 55 identified cases across 12 states of the rare form of the highly drug-resistant bacteria P. aeruginosa.
On Feb. 2, the FDA recommended a recall of the products, in part, due to Global Pharma Healthcare’s numerous manufacturing violations, including:
-Lack of appropriate microbial testing
-Formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative)
-Lack of proper controls concerning tamper-evident packaging
The FDA then placed the company on import alert, preventing these products from entering the U.S.
Global Pharma Healthcare initiated a voluntary recall of its artificial tears products on Feb. 2. The company agreed to a recall of its eye ointment on Feb. 22.