INTRODUCTION:

Product recall system is a fundamental component of a company’s products safety management system. However experience has shown that this is an area of operation that tends to be given insufficient management focus¹. A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence (which can cause costly legal penalties) and to improve or avoid damage to publicity. Recalls are costly to a company because they often entail replacing the recalled product or paying for damage caused by use, although possibly less costly than consequential costs caused by damage to brand name and reduced trust in the manufacturer².

Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance with any governmental health agency regulations and requirements governing distributed products. This applies to all products manufactured and distributed from a site, including physician samples and commercial products used for market studies and clinical trials³.

The world health organization’s guidelines for good manufacturing practice specify that a company must make provision for recall or withdrawal of pharmaceutical products where necessary. Most countries have introduced corresponding provisions into their law, either relating to all types of product or specifically to pharmaceuticals.

Safety (or other) problems which justify product recall may be such that they relate only to a single manufacturing batch identifiable by number (e.g., microbial contamination of an intravenous fluid due to a machine fault) or to an entire product. In both cases, the duties which law and ethics impose on the manufacturer will be similar:

a. To cease at once to supply the product or batch concerned

b. To warn the health professions immediately to stop further prescribing, dispensing and intake of the material, providing reasons for the warning

c. To warn the public with appropriate urgency and prominence to return the product to the pharmacy or retailer and (in case of prescription product) to ask the physician for an alternative prescription

d. To collaborate closely with public health authorities so as to ensure that the measures taken are appropriate and efficient

It is evidence that a patient could be succeed in a claim against manufacturer for injury which was a consequence of the latter’s having failed to put a product recall or withdrawal into effect when this was needed; it will be for the court to judge whether the situation in fact justified recall or some other measure (e.g. a warning) which might from an alternative cause of action⁴.

Category of Drug recall:

A drug recall occurs after the Food and Drug Administration receives numerous adverse reaction reports from physicians in regards to a particular drug, or after the manufacturer realizes that there was a deficiency in their manufacturing process. To put it simply, a drug recall removes the affected prescription or over-the-counter drug from the market. Generally, a recall must be warranted by the high likelihood that the drug will cause extremely serious injury or death. While all drug recalls are not to be taken lightly, the FDA classifies them as Category I, II or III.

Category I: The use of, or exposure to, the recalled drug is most likely capable of causing a serious health issue or even death to the consumer.

Category II: The use of, or exposure to, the recalled drug is not likely to cause a serious health issue. At most, it may cause temporary or medically reversible adverse health consequences.

Category III: The use of, or exposure to, the recalled drug is not likely to cause an adverse reaction⁵.

Examples of Class I recalls are foods found to contain botulinal toxin, foods with undeclared allergens, or mislabeling a life-saving drug. A drug that is under-strength but not used to treat life-threatening situations is one example of a Class II recall; another is where two units of blood are collected from a donor who has traveled to a country where malaria is endemic. Class III recalls might include container defects such as a lid that does not seal, a product that is off-taste or color, or a retail food that does not have a label in English⁶.

As technology progresses, patients and pharmacies have seen an influx of new drugs onto pharmacy shelves. While this is beneficial to most, many patients suffer serious and often deadly side effects from these potential life-saving medications.

Following receipt of numerous adverse reports regarding a drug, the manufacturer or the Food and Drug Administration (FDA) may issue a warning, or in more serious cases, a recall, to communicate the possible dangers to consumers. According to an analysis of FDA data, in 2008 there were 426 drug recalls, and in 2009, there were a staggering 1,742 drug recalls. From January to June of 2010, 296 drug recalls have already taken place, with more anticipated in the coming months. Recalls may be issued in response to the discovery of a manufacturing defect, a design defect or a labeling defect.

Manufacturing defects account for the majority of recalls. Manufacturing defects typically occur when something goes wrong during the manufacturing process, such as when a batch of drugs produced at a facility deviates from their proper design specifications, or the drugs are adulterated or contaminated with other substances. Quality control concerns at a facility may also prompt a manufacturing defect recall. Manufacturing defects may also occur when the packaging itself is not manufactured according to approved specifications such as when a product is mislabeled – e.g. the wrong dosage is indicated on the packaging or the labeling omits important information or warnings. Typically, manufacturing defects affect only certain "lots" or batches of drugs. The affected or recalled lots are usually published on the FDA and/or manufacturer’s website.

In contrast, design defects do not involve a problem with the manufacturing process. Rather, a design defect exists when a product is manufactured according to its proper specifications, but does not perform as marketed or intended, or presents unreasonable risk of injury. A design defect typically occurs when studies, additional data, or adverse event reports indicate that a drug may unreasonably increase the risk of a serious side effect. In some cases, the drug's label or prescription information may be deemed defective if it fails to disclose risks, side-effects, study data, and other important information. Design defects may corrected by revising the label to include updated information. However, in more serious cases, a defectively designed drug may result in a complete, product-wide recall.

The FDA and manufacturer may agree to keep the product on the market but with stricter warnings and updated prescription information. The strictest warning the FDA can demand is a "black box" warning.

Given the frequency and volume of recent recalls, the FDA and pharmaceutical industry have both come under severe criticism for failing to do more to safeguard the public against potentially dangerous drugs⁷.

How Recalls may Happen:

Recalls may happen in three ways. First, a manufacturer or distributor may decide on its own initiative to issue a recall to remove a product from the market. Second, FDA may request a recall. Finally, two things can happen in the rare instances where a firm does not comply with FDA request.

In certain circumstances the FDA has statutory authority to order a recall; in other cases the FDA must seek legal action under the Food, Drug, and Cosmetic Act. The FDA can prescribe a recall only when a medical device, human tissue products, or infant formula pose a risk to human health. Legal remedies available to FDA include seizure of the available product, an injunction against the manufacturer, and/or a court request for recall of the product.

A market withdrawal is a less drastic step than a recall. A market withdrawal is voluntary on the part of a manufacturer, and occurs when a product has a minor violation that would not otherwise be subject to FDA legal action. In these cases, a firm will remove its product from the market or otherwise correct the problem. For example, a product will be removed from the market if there is evidence that its packaging has been compromised. This can happen without any manufacturing or distribution problems.

A medical device safety alert is issued in situations involving a medical device that presents an unreasonable risk of substantial harm. These are primarily intended to inform potential users of possible hazards. In some cases, these alerts also are considered recalls⁸.

FDA Drug Recall:

An FDA drug recall is based on medical research and clinical trials. FDA recalls are frequently in the news. In order for a drug medication to be approved, the FDA must find it both safe and effective. Sometimes a drug is not dangerous, it is just ineffective. An arm of the FDA called the Center for Drug Evaluation and Research (CDER) reviews the reports of a drug’s studies so that the Center can evaluate the data. Hospitals and clinics around the country and the world conduct these studies. The pharmaceutical companies pay for these studies.

Congress in 1992 passed the Prescription Drug User Fee Act (PDUFA). This law allows corporations to provide CDER researchers with money to speed up the FDA approval process. In four years the FDA was approving drug medications at twice the rate. They received over $300 million annually for pharmaceutical companies. Some people think that this accelerated approval process has led to more FDA recalls. This cannot be proven. Since 1980, the approximate time between FDA approval and FDA recall for drug medications is just over five years.

An extreme case of recall occurred with the drug phenylpropanolamine (PPA). It remained a stroke suspect for twenty years before a Yale University study confirmed the link between PPA and hemorrhagic strokes. The FDA recalled the drug in 2000. Estimates are that PPA caused 200 – 500 strokes in people less than 50 years of age every year.

What is FDA Recall:

The FDA openly acknowledges that not all effects of a drug medication are documented or even known at the time of approval. This is because safety standards for the drug are performed on small groups of patients.

Very rarely does the FDA, working under the statutes of the Federal Food, Drug, and Cosmetic Act of 1938, confiscate a product or “order” a recall. Instead, the FDA usually requests a company to recall its product. Companies comply because of bad publicity or the threat of lawsuits. Because of the bad publicity for the FDA that certified the recalled drug as safe, sometimes the FDA will work with pharmaceutical companies and doctors to alter the warning labels until the point when the drug medication proves too dangerous to keep selling.

The product recalls by a pharmaceutical company fall into three categories.

Class I recall – There is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Class II recall – The use or exposure to the product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.

Class III recall – The use or exposure to the product is not likely to cause adverse health consequences.

The most recent FDA recall news item involves the diet drug, Meridia. There are studies linking the drug to cardiovascular problems including heart attacks and strokes. The FDA panel was split. Eight members called for withdrawal; six members called for restricted sales and a “black box” warning; two members called for the warning plus close monitoring of patients. The FDA’s own monitoring linked 14 deaths to the use of Meridia. The FDA first approved Meridia in 1997, and it increases the risk of heart attack and stroke by 11 percent, while doing little to assist with weight loss⁹.

Handling and Decision making of Recall Products in Pharmaceutical Companies:

Federal Food and Drug and Cosmetic Act:

While the existence of numerous drug recalls may lead many to believe that FDA has the legal authority to require a recall of drug products, at present the Federal Food and Drug and Cosmetic Act (“FFDCA”) does not grant FDA this power. FDA does have the power to recall products approved as medical devices and those approved as biological products. The recall authority for medical devices is part of the Medical Device Amendments to the FFDCA; the recall authority for biological products is part of the Public Health Service Act. Similarly, FDA has no recall authority for foods or cosmetics; that possible grant of authority is subject to other pending legislation.

As the situation now exists, recalls of drug products are a voluntary action undertaken by pharmaceutical companies when they become aware of the possibility that one of their products may be adulterated or misbranded. If the product is subject to a New Drug Application (“NDA”), there is a requirement that the NDA applicant notify FDA within 3 working days of the receipt of:

1. Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article.

2. Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application. Such a filing is called an NDA Field Alert Report.

Handling and Decision making:

Most companies have a recall procedure in place whereby such information is reviewed, and a decision is made by an interdisciplinary group of employees as to whether a recall should be undertaken, and, if so, to what level of trade (consumers – class 1; retailers – class 2; or wholesalers – class 3) the recall should extend, based on an evaluation of the safety risk involved. The company notifies the FDA of the decision and keeps FDA aware of its actions, including its notifications to the trade and, if necessary, consumers, in accordance with FDA regulations on recalls.

Under the proposed legislation, a drug company would be required to notify FDA “as soon as practicable” of the identity and location of any drug products “reasonably believed” to be adulterated or misbranded, which products could with reasonable probability “cause a threat of serious adverse health consequences or death to humans or animals”. The Agency would have the power to request a voluntary recall or could issue an order requiring that the company immediately cease distribution of the drug product, and to provide notice to “persons who may be affected by such cessation of distribution”. A company could appeal the order within 24 hours, by requesting an informal hearing that FDA has to provide in 5 days. Following the hearing, the Agency can decide to order a recall of the drug product in question or it can vacate the distribution cessation order. A recall order, if issued, would be required to:

a. Specify a timetable in which the recall will occur.

b. Require periodic reports to the Secretary describing the progress of the recall; and

c. Provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

There is, under the draft legislation, in addition, the possibility of an “emergency recall order”, where the FDA finds that there is an “imminent” threat of serious adverse health consequences or death to humans and animals. In such cases, the recall order becomes effective immediately. There is the same provision for an appeal if filed within 24 hours of issuance of the recall order and an informal hearing within 5 days. The recall is to continue, regardless of any appeal of the emergency recall order.

The bill would also provide that failure of a company to provide a required notice or for the company to comply with an order (recall/cessation of distribution) is a criminal violation under the FFDCA. There are specific provisions as to what Agency officials are authorized to issue the orders. It also is made clear it does not affect recall authority currently in place for devices and biologics.

The legislation, as drafted, seems only to require the notification, recall and notice to affected customer in situations traditionally considered Class 1 recalls, since it is limited to situations involving serious adverse health consequences or death. The legislation would not require recalls in Class 2 or Class 3 situations. In addition it would require a recall only where the risk of serious adverse health consequences is “imminent” or “reasonably believed” to be probable, which is interesting as it would not rectify the problem that occurred with Johnson and Johnson children’s products. In that case, the risk of serious adverse health consequences was deemed “remote”. In addition, the legislation does not distinguish between “imminent” and “reasonable probability”.

Fig1: Recall decision flow chart

The legislation appears to be based on similar wording found in Section 518(e) of the FFDCA providing recall authority for medical devices, although there are some differences. The medical device provision does not include an “emergency recall order”. In addition, the informal hearing, in case of an appeal, would need to take place in 10 days, not 5 days. In the past, the FDA has sought to require recalls under its general enforcement powers, but has largely been rebuffed by the courts as “an additional arrow” not needed given its “already well equipped bow”. As far back as 1975, commentators have suggested that FDA needed drug recall authority. While FDA has never vigorously sought such authority, the time for “total recall” authority for medical products may be near¹⁰.

How to Recall Investigational Drug and Medical Device Products:

Recalling an investigational product is a little easier than recalling a marketed prescription drug or device. Marketed drug products and devices are on pharmacy shelves, in the doctors' office or in the consumer's home and that can make recovery difficult.

Instructions:

1. Develop and implement written procedures on product recall. The procedure should clearly identify what circumstances could result in a recall. The procedure should also identify each person involved in the process and their responsibility to recover the product. All personnel involved with an investigational drug or device should be encouraged to contact management immediately if they notice serious or life-threatening problems with a drug or device. A written procedure with names and numbers and reporting process should be available to all employees, consultants, and vendors.

2. Investigate and document the problem. Quality Assurance typically handles this part. However, information regarding the reported problem should be investigated. Determine if the report is accurate and if a recall is necessary. It is a very serious step and one that you do not want to make on a whim. Either way, you need to show the authorities all actions taken to protect the subjects.

3. Immediately contact the principal investigators site and inform them to stop dispensing the investigational drug or device product. If contacted by telephone, follow up with a written communication.

4. Instruct the principal investigators to contact the clinical research subjects and have them return the product within a specified timeframe (e.g. 1-2 days) even if you have pay to for their transportation.

5. Tell the clinical site to document all information related to the amount returned (if it is a drug), who returned it, date returned and the status of the product when it was returned.

6. Ensure that all products are retrieved and returned to you immediately.

7. Perform a reconciliation of the product to ensure all of it has been returned.

8. Summarize all actions taken in a report. Ensure the report describes the date you were notified of the problem, the date of the recall, titles and names of key decision makers and the date the product was reconciled. It is also important to note if you were able to recover all of the investigational drug or device product¹¹.

Addressing drug and device recalls in hospitals:

Actions for recalls:

A product recall includes any notice from a drug manufacturer, wholesaler and/or FDA to return a drug product or medical device due to suspected contamination or defect. For ease of discussion throughout this discussion, “drug product” also includes medical device.

Pre-Recall Planning:

The pharmacy department has direct authority and ultimate responsibility for implementation of the facility’s recall policy and procedures. To achieve this, the hospital’s administration needs to provide full support to the pharmacy department in executing the duties. The pharmacy department should develop and implement written policies and procedures for the effective and efficient removal of recalled products from all patient care areas (inpatient and outpatient) and storage areas. However, policy and procedure development must be multidisciplinary in approach. At a minimum, representatives from nursing, medicine, pharmacy services and administration should be involved. The focus should encompass all patient care areas, including outpatient services.

a. Components of Written Procedures for Recalls:

Develop a duties or detail list with all steps needed to be taken during a recall so that any staff member can effectively carry out the steps. The procedures should identify the specific roles and responsibilities of all personnel involved in the recall process in sufficient detail to ensure maximum compliance. For many hospitals, a dedicated and trained recall team that knows all the policies, procedures and pertinent regulations will provide best support to the hospital in responding consistently in handling recalls. In other hospitals, fewer staff may be involved. Ensure knowledge of drug recall procedures by developing facility-wide systems and providing periodic training at least annually. Ensure that:

• Staffs understand federal and state regulations governing drug product or medical device recalls.

• Communication occurs about all pertinent recall information and a notice of the recall is distributed to all impacted areas and appropriate staff in a timely manner.

• Various communication avenues throughout the organization are used to spread notices of recalls (email, fax inter-campus, interoffice mail, hospital newsletter – some of these methods are too slow but can serve as reminders).

• Flyers are posted about recalls; for example, post flyers saying “bad heparin” with the lot numbers recalled.

• There is a centrally located repository of recall notices that is readily retrievable.

b. Know All Drug Storage Areas in Hospitals:

• Maintain control over drug storage everywhere in the hospital.

• Identify all locations where drugs are kept throughout the hospital: prohibit storage outside these areas.

• Allow no drugs in the hospital that were not purchased through the pharmacy. There should be no allowance for drugs to be brought in for patient use without the express knowledge and approval of the pharmacy department.

• Medical devices should be inventoried and controlled in a manner that facilitates their rapid location by the manufacturer model product or serial number.

• Minimize the number of and maximize the quality and authority of the individuals carrying out monthly inspections.

• Ensure that someone is authorized to do what is necessary to secure the drug supply throughout the facility. During monthly inspections, check for recently recalled drugs to double check they have been removed from the hospital’s supplies.

c. Once a Recall Has Been Initiated:

• Establish a centralized method to receive, interpret and disseminate information about recalls, especially Class 1 recalls.

• Assess the actual or potential clinical significance of the recall on patient care, and identify alternative drug therapy for recalled drugs or devices.

• Specify who is responsible for checking specified drug storage areas and obtain a signoff by the individual conducting the check. Establish timelines for completion of each task.

Establish a method to ensure all drug storage areas are checked, and then perform an audit. For example, after recall notices are faxed to all pharmacies, require all responses confirming that all recalled drugs have been removed be returned within 72 hours. After the faxes are received, consider double checking via audit of the drug storage locations.

• Ensure that recalled drugs and devices are stored by the pharmacy in an area clearly designated as a quarantine area until disposed of as directed in the recall notice.

d. Additional Steps:

• Monitor subsequent product shipments to ensure recalled products are not shipped into the facility.

• Establish a system by which patients who may have been affected by the recalled product are identified and the patients’ primary physician is notified and provided with recall information.

• Establish a system to monitor implementation on a regular basis to provide insight into opportunities for process improvement.

e. Quality Assurance and Process Improvement:

Implement monthly reporting of recall activities. Such reports should include

• The number of recalls received by the organization

• The number of recalls requiring action by the organization

• The length of time from receipt of the recall notice until closure is attained.

• The number of patients affected or potentially affected, including any adverse outcomes.

• The location and quantity of recalled product returned.

• Share these reports with staff to review and identify opportunities for process improvement.

• Identification of any problems encountered with the recall process.

f. Activities with Drug Wholesalers to Improve Recalls:

• Have a wholesaler representative dedicated to the hospital or hospital group. Alternatively, designate one person as the hospital’s liaison with the wholesaler. This person can run reports and identify recalled drugs purchased by the hospital.

• Collaborate and communicate with the wholesaler on drug shipments and recalls, including shipments after a recall is announced.

Improvements for the recall system:

Notification System for Recalls Needs Improvement:

Have a more effective recall notification system that originates in one place, listing what the issue is, what should be done; what steps should be taken, etc. Having one notice from one source with all the relevant information would minimize confusion.

• Encourage the FDA to develop a standardized format for recalls, including listing the reason for the recall, so adherence is easier to achieve.

• Recall notices should state whether the recall is a Class I, II or III recall. Also, notices should have clear instructions about what actions to take.

• Encourage wholesalers to communicate recalled lot numbers to purchasers of their products.

• Recalled products repackaged under another name or brand by a different distributor should be recalled by all names, and a separate recall notice should be listed for the distributor.

Establish Tracking of Drugs throughout the Hospital:

Institute bar coding to better track drugs throughout the facility, Hospitals need to prioritize bar coding technology. Electronic tracing or notification (e.g., secure email) of recalls would be helpful.

Institute bar codes and advocate having standardized methodology in the way the information is sequenced. This should apply to the entire lifecycle of the product, so a recalled product can be identified in the hospital. E-pedigree requirements would enable better execution of a recall within a hospital.

Methods of Obtaining Recall Information:

Redundant notification systems should be established to ensure the facility receives recall notices. Facilities are encouraged to subscribe to more than one method available for product recalls.

Recall notices can arrive at hospitals via fax, certified letter, standard mail, e-mails from manufacturers, wholesalers, or notices with invoices for other drugs. Closely working with the hospital’s drug wholesalers will improve notice and distribution of recall information.

Administrative Policies:

Require that drugs be stored in specific locations and institute consequences when drugs are stored out of these areas. Increase the authority of the pharmacist-in-charge to better control where and how drugs are stored.

Expand policies to increase responsibility of other department heads during a recall. All health care providers that are touching the drug are accountable.

“Geographic” Concerns:

Ensure there is a system to identify all outpatient clinics and other departments that are on the facility’s license. This will help clarify what a pharmacist-in-charge is responsible for.

• Establish guidelines for an authorized medication storage area.

Outside medications from vendors or contractors should not be allowed in the hospital¹².

CONCLUSION:

Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance. FDA has statutory authority to order a recall; in other cases the FDA must seek legal action under the Food, Drug, and Cosmetic Act. The FDA can prescribe a recall only when a medical device, human tissue products, or infant formula pose a risk to human health. And finally it is concluded that Pharmaceutical products are plays an important roll in health care system so these products should be manufactured in correct manner as per GMP and/or other norms or act to avoid product recall and withdrawal.

REFERENCE:

1. British Retail Consortium. .Product Recall Guidelines: A Good Practice Guide for Product Recall, London 2003

2. Wikipedia .Product recall. Available from: http://en.wikipedia.org/wiki/Product_recall, 19 April 2011

3. GMP Online Consultancy, Product Recall Standard Operating Procedure. Available from: http://www.gmp-online-consultancy.com/e/html/301_direct_order/210_standard-operation-procedures_detail.php?docIndex=97

4. G. Dukes, Mark Mildred, Barbara Swartz. Responsibility for drug-induced injury: a reference book for lawyers, the health profession and manufacturer, Netherland 1998

5. Drug warning, recall and news. Available from: http://www.drugrecalls.com/drugrecalls.html

6. USlegal, food, drug, cosmetic recalls. Available from:http://consumerprotection.uslegal.com/manufactures-product-recall/food-drug-and-cosmetics-recalls/

7. Drug warning, recall and news. Available from: http://www.drugrecalls.com/drug-warnings-and-recalls.html

8. USlegal, food, drug, cosmetic recalls. Available from: http://consumerprotection.uslegal.com/manufactures-product-recall/food-drug-and-cosmetics-recalls/

9. Margaret Stenerson. FDA Drug Recall. Available from: http://www.regaffairs.net/more-about-fda-drug-recall.html Sep 2010

10. Peter Reichertz, Sheppard Mullin. Has time come for total recall of medical products. Available from: http://www.lifescienceslawblog.com/2010/07/articles/legislation/has-the-time-come-for-total-recall-of-medical-products/

11. Ehow heath. How to Recall Investigational Drug and Medical Device Products, Available from http://www.ehow.com/how_4677665_investigational-drug-medical-device-products.html#ixzz1Hvd9Ej1I

12. Kenneth H. Schell, Randy B. Kajioka,, Stanley C. Weisser, Addressing Drug and Device Recalls in Hospitals. California 2010

13. FDA us food and drug administration. Recalls, Market Withdrawals, and Safety Alerts. Available from http://www.fda.gov/Safety/Recalls/default.htm

Received on 23.04.2011 Modified on 19.05.2011

Research J. Pharm. and Tech. 4(9): Sept. 2011; Page 1333-1339

Date	Brand Name	Product Description	Reason/ Problem	Company
03/26/2011	Greenstone	Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle)	Bottles may contain wrong drug	Greenstone LLC
03/25/2011	Toxic Waste® Short Circuits™	Bubble Gum	Elevated Levels of Lead	Circle City Marketing and Distributing, dba Candy Dynamics
03/25/2011	APP Pharmaceuticals	Irinotecan Hydrochloride Injection	Fungal microbial contaminant particulate matter	APP Pharmaceuticals, Inc.
03/24/2011	Mai's Bakery	Hopia Mongo and Moon Cake Products	Undeclared Egg	Mai's Bakery, Inc.
03/23/2011	Cottage Hearth, 7 Select	Wheat Bread	Undeclared Milk	Unified Grocers
03/22/2011	U-Prosta	U-Prosta Natural support for prostate health	product contains terazosin, the active ingredient of an FDA-approved drug used to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug	USA Far Ocean Group Inc.
03/22/2011	Samlip	Red Bean Bread	Undeclared Egg	Seoul Shik Poom Inc.
03/22/2011	Del Monte	Cantaloupes	Salmonella Panama	Del Monte Fresh Produce N.A., Inc.
03/21/2011	Millar Mikro-Tip	Angiographic Catheters	Particulate debris within the catheter lumen	Millar Instruments, Inc.
03/21/2011	Lakeside, Bountiful Harvest, Code Elite, more	Pickled Sliced Beets	May be under processed - risk for botulism	Lakeside Foods, Inc¹³.