Aminocaproic Acid

VistaPharm, Glemark Pharmaceuticals, Teva and Apotex all issued voluntary recalls posted on the FDA website. The FDA posted a flurry of voluntary drug recalls by drug manufacturers on its website. Below are the companies and products being recalled. VistaPharm issued its Class III recall Oct. 17 for more than 2,300 bottles of aminocaproic acid oral solution that is used to treat serious bleeding conditions, especially when the bleeding occurs after dental surgery or other kinds of surgery. The company cited failed specifications for the action, specifically, a high content of ethylene glycol. Where the product was manufactured was not provided. The bottles were distributed nationwide in the U.S. Class III recalls involve products that violate federal regulations but are unlikely to cause adverse health consequences. Aptotex issued four separate Class II recalls Nov. 1 for more than 149,000 bottles distributed nationwide in the U.S. of prescription-only paroxetine hydrochloride tablets that are used to treat a variety of conditions, including depression, obsessive-compulsive disorder and panic disorder. The company cited failed impurities and/or degradation, out-of-specification results. The products were manufactured at the company’s Toronto production site. A Class II recall is issued with a product has a lower chance of causing major injuries or death, but it is still possible for serious enough adverse events to have irreversible consequences. Glenmark Pharmaceuticals issued two separate Class II recalls for products due to a mislabeling issue involving Indomethacin and Naproxen. The recalls for both were issued Nov. 7. The company recalled 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms. It recalled five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain due to headaches and muscle aches and other minor maladies. Both products may have been mislabeled as the other, the company said. The drugs were manufactured at both the Glenmark facility in Goa, India, and the company’s New Jersey facility. Teva issued a Class III recall for one lot of 30 unit-dose packets per carton of testosterone gel due to out-of-specification issues related to viscosity. The product, which was produced at the Teva facility in North Wales, Pennsylvania, is used to treat hypogonadism in men. The recall was issued Nov. 10 for the lot that was distributed nationwide in the U.S.