Weekly FDA Enforcement Report For Drugs And Biologics 4/16/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 16, 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: Slim Beauty USA of Kearney, NE recalled three products: Dr. Ming's Chinese Capsule, Magic Slim capsules, and Dream Body Slimming Capsule due to undeclared sibutramine and phenolphthalein. American Lifestyle from Pittsford, NY recalled Vicerex A Powerful And Fast Acting Male Sexual Enhancer and Black Ant due to undeclared tadalafil and sildenafil. RX Formulations Services recalled Calcium Gluconate 10% for Injection due to microbial contamination.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Biologics: No Class II biologics recalled this week.
- Drugs: RX Formulations Services recalled Magnesium Sulfate, Potassium Phosphates, Oxytocin, Sodium Bicarbonate, Bupivacaine, and Vitamin B-12 injections due to poor aseptic practices. Agila Specialties Private Ltd. recalled Etomidate injection due to the presence of particulates. Terra-Medica Inc. recalled Pleo Not, Pleo Nota-Quent, Pleo Quent, Pleo Fort, Pleo Ex, and Pleo Stolo (ointment, suppositories, capsules, tablets, drops, and portable sips) due to penicillin cross contamination.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Biologics: No Class III biologics recalled this week.
- Drugs: Novartis recalled Ritalin HCl (methylphenidate HCl) USP, 10 and 20 mg due to Medication Guide errors. Hospira recalled Demerol injection due to a missing label. Boehringer Ingelheim Roxane Inc. recalled Spiriva HandiHaler due to interaction of the drug product powder with the lubricant on the interior of the capsule shell.