Downing Labs, LLC recalls Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injectio
Recalled November 25, 2015 · FDA recall D-0353-2016 · Downing Labs
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
2189 vials
Sold at
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Description
Lack of Assurance of Sterility
Product
Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Manufacturer(s)
Downing Labs, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →