Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages
The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public. 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 and illustrated the “FDA Response to Drug … [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...]
