[2/16/2016] The U.S. Food and Drug Administration is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, in Noblesville, Indiana, because the product is super-potent. Pharmakon initiated the voluntary recall on February 11, 2016, after receiving laboratory results showing the product was super-potent.
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
- Must comply with current good manufacturing practice requirements;
- Will be subject to inspection by FDA according to a risk-based schedule; and
- Must meet certain other requirements, such as reporting adverse events and providing FDA with certain information about the products they compound.