Weekly FDA Enforcement Report For Drugs 8/13/14
By Cyndi Root
The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 13, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification, the danger level.
Classification I Drug Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
In the one Classification I drug recall this week, Alexion Pharmaceuticals from Cheshire, CT recalled Soliris (eculizumab), for prescription only. The voluntary recall spans nationwide and includes Puerto Rico. The company recalled the drug because of the presence of visible particles. The company issued a recall of Solaris in June 2014, due to the presence of particles, but said that it had identified the source of problem and corrected it.
Solaris treats paroxysmal nocturnal hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS). The drug inhibits the terminal complement pathway which is believed to play a role in the pathophysiology of PNH and aHUS. Recently, Alexion announced in a press release that the European Commission (EU) granted Solaris Orphan Drug Designation for the treatment of Myasthenia Gravis (MG), a neurologic disorder.
Classification II Drug Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
- Janssen recalled Risperdal Consta (risperidone) due to sterility concerns.
- Medical Supply Liquidators from Clive, IA is not a registered FDA drug manufacturer and therefore, recalled several products including Vitamin B12, Vitamin B6, BCAA, B Complex, and Lipo 8 injections.
- Caraco Pharmaceutical Laboratories recalled Cephalexin Capsules, 250 and 500 mg, due to deficiencies in cGMP manufacturing. SST recalled Tetrahydrozoline HCL because of improper storage in a non-GMP compliant warehouse.
- Mckesson Packaging Services recalled Alprazolam tablets due the presence of metal particulates. Last week, the company recalled Aspirin because it failed dissolution specifications.
- HLI dba Humphreyline recalled Alcohol-Free Hand Sanitizer because of microbial contamination.
Classification III Drug Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
- Wockhardt USA recalled Buproprion HCl Extended-Release Tablets manufactured by Wockhardt Limited in Mumbai, India. The company issued the nationwide voluntary recall due to the levels of m-chlorobenzoic acid impurities.
- Novartis recalled Cataflam (diclofenac potassium), a nonsteroidal anti-inflammatory drug (NSAID), manufactured by Patheon in Ontario, Canada.