Weekly FDA Enforcement Report For Drugs And Biologics 4/23/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 23, 2014. The agency publicizes recalls in its weekly report. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification (the danger level.)
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
- Biologics: No Class I biologics recalled this week.
- Drugs: Haute Health, LLC from Williamstown, NJ issued three recalls nationwide and internationally via internet sales. Prolifta Dietary Supplement, PHUK Sexual Enhancement Ultimate Pleasure, and Virilis Pro were recalled due to marketing without an approved NDA/ANDA, as the products may contain amounts of an active ingredient found in drugs for erectile dysfunction (ED). Hospira of Lake Forest, IL recalled 1 % Lidocaine HCl Injection because of oxidized stainless steel found in the vial. B @ B Trade Inc. of North Miami Beach, FL recalled Slim Fortune, Lidiy, and SlimExpert due to undeclared Sibutramine, which means it was marketed without an approved NDA/ANDA.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: The American National Red Cross from Columbus, OH recalled Red Blood Cells (Apheresis) Leukocytes Reduced and Platelets Pooled Leukocytes Reduced due to donor unsuitability. Carter BloodCare from Bedford, TX recalled Red Blood Cells Leukocytes Reduced and Platelets due to donor unsuitability. Lifesouth Community Blood Centers recalled Platelets Pheresis Leukocytes Reduced due to low pH. OneBlood from Hialeah, FL recalled Red Blood Cells Irradiated, Cryoprecipitated AHF, Platelets, Fresh and Frozen Plasma, and Red Blood Cells due to a donor whose suitability to donate was not fully evaluated.
- Drugs: No Class II drugs recalled this week.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: The American Red Cross of Toledo, OH recalled Red Blood Cells and Platelets because of possible donor unsuitability. The American National Red Cross from Saint Paul, MN recalled Red Blood Cells Leukocytes Reduced due to the donor’s report of having had a shingles vaccination prior to donation.
- Drugs: No Class III drugs recalled this week.