Recalls, product

In 1982, seven people died from consuming cyanide-laced Tylenol capsules. The incident resulted in a total product recall, massive negative pubHcity for the product, new requirements for safe packaging, and a federal statute making product tampering a crime (2). Since that time, the packaging industry has become visible to most consumers. This awareness has benefited the consumer by a reduction in loss of life due to consumption of adulterated products from tampering. Never before has an industry reacted so swiftly to resolve a problem. 

Efforts to commercialize larger versions of rechargeable lithium cells have been fmstrated by concerns over product safety. MoH Energy Ltd. briefly introduced "AA" Li—M0S2 cells for OEM use in laptop computers and cellular phones. However, safety issues resulted in a product recall and a halt to commercialization of this product. 

Failure costs - Internal failure costs are essentially the cost of failures identified and rectified before the final product gets to the external customer, such as rework, scrap, design changes. External failure costs include product recall, warranty and product liability claims. 

As stated previously, traceability is fundamental to establishing and eliminating the root cause of nonconforming product and therefore it should be mandatory in view of the requirements for Corrective Action. Providing traceability can be an onerous task. Some applications require products to be traced back to the original ingot from which they were produced. In situations of safety or national security it is necessary to identify product in such a manner because if a product is used in a critical application and subsequently found defective, it may be necessary to track down all other products of the same batch and eliminate them before there is a disaster. It happens in product recall situations. It is also very important in the automobile and food industries in fact, any industry where human life may be at risk due to a defective product being in circulation. 

If you need to recall product that is suspected as being defective you will need to devise a recall plan, specify responsibilities and time-scales, and put the plan into effect. Product recall is a remedial action not a corrective action, as it does not prevent a recurrence of the initial problem. 

The standard does not address product recall other than in the context of releasing product for urgent production purposes in clause 4.10.2.3. The reported nonconformities from your customers may be so severe that you need to recall product, not just one or two but a whole batch or several batches between two dates or serial numbers. Product recall can be considered to fall within the scope of handling reported nonconformities ... 

It should be noted that very few standard product liability policies provide cover for liability for the costs of repairing or replacing defective products or those, which fail to perform as intended, nor for the costs of any necessary product recall. The insurer s liability in any one period of insurance for injury or damage caused by products during that period shall not exceed the selected limit of indemnity. 

Complaints, product recall and emergency unblinding - complaints and recall procedures... 

The regulatory authorities must be informed of any planned recall actions (see Chapter 12). Procedures are also required for emergency un-blinding of materials undergoing clinical trial. The responsibility for complaints and the initiation of product recalls should be assigned to designated individuals. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

This system is also used where an urgent product recall is required because of safety issues arising from quality problems during manufacture, for example a labelling mix up or the contamination of a sterile product. The authorities must be advised immediately of any situations where such action is contemplated, while a report on the effectiveness of the recall should be furnished at the end of the process. 

Only after QC personnel are satisfied that the product meets these specifications will it be labelled and packed. These operations are highly automated. Labelling, in particular, deserves special atten-tioa Mislabelling of product remains one of the most common reasons for product recall. This can occur relatively easily, particularly if the facility manufactures several different products, or even a single product at several different strengths. Information presented on a label should normally include ... 

At one point, a product recall was considered. What considerations do you think a company makes before issuing a recall What are the implications of a product recall ... 

The FDA carries out two types of inspections surveillance inspections and compliance inspections. Surveillance inspections are the biennial inspections. Compliance inspections are to follow-up on previous corrective actions. Compliance inspections also include For Cause Inspections, which are inspections to audit a specific problem that has come to the FDA s attention, for example, product recall and industry or public complaints. There are two options of inspections (1) the Full Inspection Qption and (2) the Abbreviated Inspection Qption. 

The following are examples of some of the typical violations leading to drug product recall according to the FDA ... 

TABLE 4 Nonsterile Pharmaceutical and OTC Products Recalled by the FDA due to Microbial Contamination Problems, 1991-1998 (n = 46) ... 

For decades, FDA has worked with product manufacturers to request, and to help carry out, the recall of illegal products from the market. Courts have disagreed on whether the FD C Act authorises an injimction that includes a requirement for product recall. As a practical matter, however, the precise legal authority of FDA on this matter is irrelevant. Manufacturers routinely cooperate with FDA on the recall of any dangerous product. FDA has established detailed administrative policy governing recall procedures. ... 

Another condition of registration is that a product recall (or similar regulatory action) in any other country, that has relevance to the quality, safety and efficacy of the goods to be distributed in Australia, must be notified to the TGA immediately. Other conditions of registration include conditions related to the sampling and testing of products and manufacturing premises. 

As shown in Table 10 New Zealand s own GMP code consists of five parts. The first part covers the manufacture of drug products and the second part the manufacture of blood products. Part 3 covers compounding and dispensing, including compounding of sterile drug products. Part 4 deals with wholesaling and Part 5 with product recalls. Parts 4 and 5 are combined in one document [31]. 

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