Weekly FDA Enforcement Report For Drugs And Biologics 3/26/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for March 26, 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 biologics recalled this week.
• Drugs: There were several Class I recalls this week. Fabscout Entertainment, Inc. recalled Cialis tablets and Silver Sword capsules due to the presence of sildenafil (Viagra). Hospira, Inc. recalled Marcaine (bupivacaine HCl) injection due to visible metal particles embedded in the vial. Baxter Pharmaceuticals recalled 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and three (3) Clinimix Injections due to particulate in the solution.

Classification II Recall

A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.

• Biologics: OneBlood, Inc. recalled several products including plasma, platelets, and red blood cells due to unsuitable donors. Mississippi Valley Blood Center recalled Cryoprecipitated AHF, Pooled, and other blood products due to a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD). Biomat USA, Inc. and CSL Plasma, among others, also recalled Class II biologics.
• Drugs: RX South LLC, DBA RX3 Pharmacy, recalled Hydroxyprogesterone Caproate due to crystallization from shipping in cold weather. Traxx International Corp. recalled Guaifenesin due to polyethylene fibers in the product. Noven Pharmaceuticals, Inc. recalled Daytrana (methylphenidate) transdermal system patch due to difficulty removing the patch from the liner. Paddock Laboratories recalled Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution because of particulate in the product.

Classification III Recall

A Classification III recall signifies that the product is not likely to cause adverse health consequences.

• Biologics: Blood Systems, Inc. and OneBlood, Inc. had more Class III biologics recalls this week. The American Red Cross of Wichita, KS recalled blood products due to unsuitable donors. The San Diego Eye Bank recalled human corneas due to donor eligibility issues.
• Drugs: Pfizer recalled Advil PM tablets due to subpotency. McKesson Packaging Services recalled Venlafaxine Hydrochloride due to failed dissolution specifications.