List of Compounding Drug Recalls in 2013

This report prepared for Congress contains a list of the recalls through May 31, 2013.  Now we have a few more to add to the list.  How many have to occur before Congress takes action?

2013 Manufacturer Recalls of Sterile CDs

As of May 31, 2013
• On May 29, 2013, Lowlite Investments (doing business as Olympia Pharmacy) announced a voluntary multi-state recall of all sterile drug products supplied to patients and offices of licensed medical professionals with a use by date of September 25, 2013, or earlier. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. No adverse events had been reported as of the date of the recall.

• On May 24, 2013, the FDA posted a notice that the CDC, the Tennessee Board of Pharmacy and the FDA were investigating reports of seven adverse events associated with compounded preservative-free methylprednisolone injections compounded by Main Street Family Pharmacy, LLC. These reports link infections, one of which is fungal in nature.4

 On May 28, 2013, Main Street Family Pharmacy, LLC recalled all sterile products with a use by
date on or before November 20, 2013.

• On May 15, 2013, the FDA announced that Pentec Health, Inc. initiated a recall of nutritional prescriptions for renal patient due to a lack of sterility assurance. No adverse events had been reported as of the date of recall.

• On May 6, 2013, the FDA alerted health care providers of concerns regarding sterility assurance for sterile drugs produced and distributed by the Compounding Shop. The FDA reports that the Compounding Shop is in the process of recalling products. No adverse events had been reported as of the date of recall.

• On April 22, 2013, Nora Apothecary and Alternative Medicine recalled all lots of sterile compounded products produced on or before April 19, 2013 due to the lack of sterility assurance and concerns associated with the quality control processes. No adverse events had been reported as of the date of recall.

• On April 17, 2013, Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, FL, recalled all lots of its sterile non-expired drug products due to a lack of sterility assurances associated with the quality control processes. No adverse incidents had been reported as of the date of recall.

• On April 15, 2013, NuVision Pharmacy recalled all lots of all compounded lyophilized products due to sterility assurance concerns. No adverse events had been reported as of the date of recall. On May 18, 2013, the FDA expanded its alert to health care providers to all sterile drug products made and distributed by NuVision.

• On April 15, 2013, ApothéCure, Inc. recalled all lots of all sterile products compounded, repackaged, and distributed by Apothécure, Inc. due to sterility assurance concerns. No adverse events had been reported as of the date of recall.

• On April 05, 2013, Green Valley Drugs recalled all lots of all sterile products compounded, repackaged, and distributed by the firm due to quality control concerns. No adverse events had been reported as of the date of recall.

Judith M. Glassgold  Specialist in Health Policy , Compounded Drugs,  June 3, 2013  Congressional Research Service  7-5700  www.crs.gov  R43082 (access on August 19, 2013).  Report also references this blog several times!