In Event of a Recall

Recently, a large multinational firm in Canada voluntarily initiated a recall of select lots of its intravenous (IV) solutions. Recall announcements are regularly in the news, at times they are initiated by the company itself and other times by the governing institution that sets the rules for that industry. Either way, in the event of a recall, companies face logistical and regulatory challenges.

Under Health Canada, drug and health products have a recall policy where the inspectorate’s “mandate is to manage and deliver a national compliance and enforcement program for drugs (human and veterinary), medical devices, natural health products… across all regions. The Inspectorate expects responsible parties to take full responsibility for product recalls, whether they are undertaken at the initiative of a responsible party or in response to an order to recall under the Food and Drugs Act.

In the United States, the Food and Drug Administration (FDA) provides guidance to companies dealing with a product recall. The FDA provides a checklist of documentation and information which it uses to evaluate, classify, monitor and audit product recalls. For example, the FDA recommends that companies include the following information in recall submission: CODES (Production Identification Numbers); Lot/Unit Numbers and; an explanation of lot number coding systems. Using a Linx laser and inkjet printer, companies are able to create a permanent, indelible code on a wide range of materials.

In case above, the company notified the public about its recall list by announcing the date coded identification on the effected lots. The company also clarified that lots marked with an alphanumeric character at the end of the code were not affected by the recall. The company used a laser printer in marking its products. Yet, for a more cost effective means of date coding, continuous inkjet printers are an ideal alternative to meet regulatory requirements in the event of a recall.

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/pol_0016_tc-tm-eng.php

http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

This entry was posted on Friday, April 17th, 2015 at 2:56 pm and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.