Another compounder is recalling a host of products because their sterility cannot be guaranteed. This latest recall joins a number of similar recalls issued in recent weeks.
Previously, a New Jersey-based compounder known as MedPrep recalled all of their compounded products after a hospital in Connecticut identified particulates in a series of items. Those contamination worries led to a recall affecting products available throughout the country.
A compounder known as Clinical Specialties issued its own recall, although the circumstances surrounding that incident were slightly different. Doctors had been administering Avastin to patients for uses that it wasn’t approved for. Five patients reportedly incurred a serious eye infection after being exposed to the Avastin that had been repackaged by the company. With sterility once again called into question, Clinical Specialties issued its recall of sterile compounded products.
Now, the Woburn, Massachusetts-based Pallimed Solutions is recalling all of their sterile compounded products because sterility can once again not be assured. This time, an inspection carried out by the state’s Board of Registration in Pharmacy and the Food and Drug Administration led to the recall. Inspectors uncovered the issue by observing particulates in a series of different products. These particulates could cause things like blocked blood vessels, embolisms, tissue damage, and a serious allergic reaction.
All sterile products compounded and distributed throughout the country by the company at the beginning of the year have thus been recalled. Available in a handful of states, including California, the products should be brought back to Pallimed. They should not be given to patients.