https://immattersacp.org/weekly/archives/2012/11/06/7.htm

All Ameridose unexpired products recalled

All unexpired products distributed by Ameridose, LLC, are being recalled, the FDA announced last week.


All unexpired products distributed by Ameridose, LLC, are being recalled, the FDA announced last week.

The recall resulted from an ongoing FDA inspection of Ameridose's facility in Westborough, Mass. Preliminary findings of the inspection have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility, according to the FDA. There haven't been any reports of infections associated with any of the products, they noted. The recall was recommended by the FDA and voluntarily conducted by Ameridose out of an abundance of caution.

Health care professionals should stop using Ameridose products at this time and return them to the firm, but they do not need to follow up with patients who received the products, the FDA said. The facility has ceased all pharmacy and manufacturing operations as of Oct. 10, 2012.

Six of the recalled products are on the FDA critical shortage list, the agency noted. Those drugs are injections of sodium bicarbonate, succinylcholine, atropine sulfate, bupivacaine hydrochloride, lidocaine hydrochloride and furosemide. The FDA is asking other current and potential manufacturers of these drugs to ramp up production to provide safe, high-quality supplies.