Category Archives: Recall

SAGENT PHARMACEUTICALS INITIATES INJECTABLE RECALL DUE TO ASEPTIC AND GMP PRACTICES (2/23/15)

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility Schaumburg, IL,Sagent Pharmaceuticals, Inc. announced on February 23, 2015 the voluntary nationwide recall of two … Continue reading

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NUTEK DISPOSABLES, INC ISSUES ALERT DUE TO POTENTIAL BACTERIA IN BABY WIPES (RECALL – 10/25/14)

FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names … Continue reading

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WHITE & BLUE LION CONDUCT NATIONWIDE RECALL OF TATTOO INK, TATTOO NEEDLES, AND TATTOO KITS DUE TO MICROBIAL CONTAMINATION (7/15/14)

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 … Continue reading

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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, … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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