A Nevada compounding pharmacy is recalling all lots of all sterilely compounded products, the fourth U.S. compounder to do so after the FDA increased inspections in the wake of the New England Compounding Center fungal meningitis outbreak. Henderson, Nev.-based Green Valley Drugs has initiated a voluntary recall based on the FDA's "observations of clean room personnel and certain aseptic techniques."

As a result, there is a lack of sterility assurance across all products compounded by the company. The list of recalled products includes several bupivacaine and bupivacaine-dexamethasone solutions, dexamethasone, gentamicin, ketorolac, lidocaine in several strengths, and methylprednisone acetate, which was the injection at the center of the NECC outbreak.

Green Valley reports that it's received "no reports of injury or illness associated with the use of [its] sterile products." In addition, there have been "no indications of endotoxins or sterility issues from independent outside testing laboratories associated with any of the products subject to this recall."

Previously, a New Jersey compounder and a Georgia compounding pharmacy initiated nationwide voluntary recalls of all their sterile compounded products, and a Massachusetts pharmacy recalled compounded ophthalmic solutions in 21 states. The FDA has pushed for codified power to regulate compounding pharmacies.

Stephanie Wasek