Annette Krawczyk-Sheets Professor Anne-Marie Yerks English Composition 106 Online 15 December 2010

During the last few years, the US has seen an alarming increase of product recalls. Businesses seem to be cutting back costs at the expense of product quality. The FDA states there are no trends which would indicate a systemic issue; however, businesses’ reaction to the downturn in the economy over the last few years may be to blame.

 This graph reports the most significant recalls based on extent of distribution and degree of health risk. These are mainly Class I recalls.  Class I recalls – results in the reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.  Market Withdrawal – product has a minor violation that would not be subject to FDA legislation.  Medical Device Safety Alert – issued when a medical device may present an unreasonable risk of substantial harm. Some cases may also be considered recalls

 Drug recalls are up 309% from 2008 to 2009  If you remove the 1,100 recalls from a single company (which was closed down), there is still a 50% increase in this one industry alone.

Effects of product recalls on people can range not having any realization of a recall to death. Contamination issues in the food industry have lead to an outbreak of Listeria, a deadly disease to young children and the elderly, and can cause miscarriages in pregnant women. At least 38 individuals became ill, and 15 hospitalized as the result of cheese contaminated with E.coli. Inconsistent manufacturing processes can lead to incorrect drug dosage, as it did in a recent recall by Caraco Pharmaceutical Laboratories in Detroit, MI. The tablets that administer their heart medication differed in thickness, thus leading to an inaccurate amount of medicine received by the patients. This error can result in cardiac, gastrointestinal, and central nervous system complications. Lacerations and serious injuries resulted from multiple infant and children’s products recalls.

Poor plant maintenance plays a major factor in contamination: o When products are not sealed, contaminants can come into contact with them. o If products require specific temperature controls, and these are not followed, bacteria can grow. o If proper pest and rodent control programs are not put in place, then infestations can occur. These infestations can lead to insects and other rodent byproducts contaminating a product. o Leaking roofs can lead to rain water, dirt, etc. mixing with products.

No Preventive Maintenance Programs: o If proper preventive maintenance programs are not established, equipment failures can occur. This can result in:  Inconsistent manufacturing processes.  Errors in manufacturing products.  Damaged products.  Ineffective products.

Raw materials and end products imported from outside US: o Raw materials are being imported from countries which do not have as strict regulations as the US. o Most imports are coming from China, which has 3 times more product recalls than the US. o Inferior raw materials going into the manufacturing process results in inferior products being made and sold. o Outsourcing end items to other countries have the same concerns: businesses are importing from countries with less strict regulations.

Businesses have reduced headcounts or replaced experienced employees with inexperienced employees to reduce costs: o Less people doing more work can lead to: o Inattention to detail on product labels. o Fatigue resulting in inaccurate ingredients or amounts of ingredients in products. o Cutting corners in research and quality testing can cause bad product to enter the public. o Incorrect training of employees resulting in manufacturing processes not followed correctly. o Too many inexperienced employees in a company may lead to: o Regulations not understood or known about. o Inadequate research on manufacturing and quality testing.

Other factors that may also contribute to the increase in product recalls: o More strict regulations put in place. o FDA states each recall is unique and do not relate to one specific trend. o Businesses are voluntarily recalling products to show the American public that they are responsible manufacturer’s. These products do not have any adverse effects on the customer.

The downturn in economy has forced businesses to cut corners, reduce headcounts, rush research, and reduce the amount of money it invests into departments that, although they are necessary, do not result in profits (i.e. quality testing, plant and equipment maintenance, etc.). This is the common denominator among many of the product recalls that have occurred over the last few years.