FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination. The products are sold by World Organix LLC, Las Vegas, Nevada. FDA laboratory analysis found that the products are contaminated with high counts of various bacteria that can cause infections, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas … [Read more...]
Pharmaceutical Pharmakon Fails to Recall all Non-Expired Drug Products Intended to be Sterile – Then Changes its Mind
The FDA on April 11, 2016 notified pharmaceutical, Pharmakon Pharmaceuticals, Inc, Noblesville, IN that all sterile operations at their facility should cease until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile. A day later (April 12, 2016), Pharmakon informed FDA that it … [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...]
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 recalled products include injectable … [Read more...]
FDA REPORTS VOLUNTARY RECALL OF ALL AMERIDOSE DRUG PRODUCTS (10/31/12)
ON-GOING INSPECTION SUGGESTS LACK OF STERILITY ASSURANCE OF INJECTABLE PRODUCTS The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., and sharing common management with NECC,  is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that … [Read more...]
