Category Archives: Recall

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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FDA ANNOUNCES VOLUNTARY NATIONWIDE RECALL OF ALL NON-EXPIRED STERILE DRUGS FROM ABRAMS ROYAL COMPOUNDING PHARMACY (12/21/13)

MICROBIAL ADVERSE EVENT CAUSES RECALL The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The … Continue reading

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PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)

NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation.  The recall, which was initiated by the firm and was voluntary, was caused by a “Lack … Continue reading

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FIRM RECALLS SUNSCREEN LOTIONS FOLLOWING RETESTING

MICROORGANISMS INCLUDE GRAM NEGATIVE BACTERIA, YEAST AND MOLDS On Monday, September 23, 2013 W.S. Badger Co. announced a voluntary recall of all lots of its 4-ounce Baby SPF 30 Sunscreen Lotion and one lot of its 4-ounce SPF Kids Sunscreen … Continue reading

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TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS

FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013.  Their five investigators issued a five Observation, … Continue reading

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FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS

IS THIS THE NEW “POSTER CHILD” FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacy”.  The FDA indicated that the rationale behind the … Continue reading

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NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK

Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC … Continue reading

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FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators — Revised Expiration Dates

Date Issued:  July 3, 2012 Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product … Continue reading

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