Weekly FDA Enforcement Report For Drugs And Biologics 4/2/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 2, 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: No Class I drugs recalled this week.

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 Leukocytes Reduced and Platelets Leukocytes Reduced. Blood Systems, Inc. recalled Platelets Pheresis Leukocytes Reduced Irradiated due to possible Propionibacterium acnes contamination. CSL Plasma, Inc. recalled several lots of Source Plasma.
• 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: Biomat USA Inc. recalled Source Plasma due to inadequate donor suitability. Mississippi Blood Services Inc., OneBlood, Inc., and Carter BloodCare recalled various blood products. The American National Red Cross from Columbus, OH recalled Red Blood Cells Leukocytes because the product was collected using trip scales for which the Daily QC (Quality Control) was not documented.
• Drugs: All the drugs recalled in Class III this week were from Hill Dermaceuticals, Inc. from Sanford, FL. The company recalled DermOtic Oil (fluocinolone acetonide) 0.01% (Ear Drops), Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil and Body Oil), Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil and Scalp Oil), Royal Pharmaceuticals DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), Seton Pharmaceuticals Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil and Body Oil), and Seton Pharmaceuticals Fluocinolone Acetonide 0.01% Oil (Ear Drops). During routine testing, fluocinolone acetonide in all of the products was found to be subpotent.