White & Blue Lion, Inc, City of Industry, CA recently recalled all lots of tattoo inks and tattoo needles due to pathogenic bacterial contamination. The recall indicated that the “use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. The recall includes all tattoo ink, tattoo needles, … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint
Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”. This Blog elicited several very interesting comments. Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the … [Read more...]
FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS
USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [Read more...]
BAXTER INITIATES U.S. VOLUNTARY RECALL OF ONE LOT OF PERITONEAL DIALYSIS SOLUTION (3/05/14)
CONTAINER-CLOSURE NON-INTEGRITY APPEARS TO PERMIT MOLD GROWTH COMMENT Baxter International Inc initiated a recall for a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose. While the recall is due to non-integrity of the container-closure, it appears that complaints of particulate matter, identified as mold, were growing within the 6000 mL bags from … [Read more...]
ISSUE WITH STERILITY CONTROLS WITHIN MANUFACTURING LEADS TO RECALL (1/16/14)
ISSUE OCCURS WITHIN VIETNAM PRODUCTION FACILITY The Mentholatum Co. recently issued a Recall for several different eye drops that were manufactured in Vietnam. Similar eye drops manufactured in Japan were not included within this Recall. The Recall was initiated due to a manufacturing review at the Vietnam production facility and involved sterility … [Read more...]
