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Tuesday, 12 January 2016

Recall – Case Studies

Case Study listing started in 2013
These recall study cases represent the two sectors of interest to GCSE-FHP (food & health).

Case Study 53:
Another infuriating report . . . while too many in the food industry are distracted by frivolous solutionsMillions of eggs removed from European shelves over toxicity fears 

Case Study 52:
Did the reports say manufacturing practices concerns during the past three years? Who has been sleeping? 

Case Study 51:
Detection of a Health Risk By a Regulatory Agency
According to the November 28, 2016 notice: “This recall was triggered by Canadian Food Inspection Agency (CFIA) test results.” Some information appeared to have been blanked out in the image posted by CFIA. By the way, with the Best Before date of 16 NO 25 shown on the label, it appears as though the product had expired before the CFIA notice. Does this expiration provide some justification on behalf of the manufacturer?

If the random test conducted by CFIA led to this recall should the company not have caught the issue from its monitoring program? The company may be at fault on two counts under U.S. regulations: 1. Negligence in failing to detect a significant food safety risk or 2. Knowingly selling product with detected evidence of possible contamination and health risk to consumers.

The label clearly indicates U.S.A. as the country of origin. Should the U.S. regulatory agency responsible for this category of product be notified by CFIA of the test results, or should they be left to independently detect the risk?

Case Study 50:
WASHINGTON, Nov. 15, 2016 – Piccadilly Fine Foods, a Santa Clara, Calif. establishment, is recalling approximately 144 pounds of beef products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products were produced with Worcestershire sauce that contains anchovies (fish), a known allergen which was not declared on the finished product label.
Who doesn’t know that this volume should be expanded? Read the full announcement and see what you think. 

How many other things are wrong with this picture? For example:

“The problem was discovered by FSIS inspection personnel during normal inspection activities. . .“ – What happened with the manufacturers routine verification/validation checks?

Products produced prior to September 29, 2016 used a different brand of Worcestershire sauce. . . “ – What happened with R&D material/supplier replacement evaluation and control procedures?

Case Study 49 - Clostridium-Caviar CFIA Notice 
 Even luxury food can kill and indifference can be the deadly mistake

Case Study 48 - Should have been labelled "LemonGLASS Basil Chicken”

. . . sickening in so many ways: "produced and packaged on March 17, March 18, April 30, and May 13, 2016 - a span of 2 months - "with extraneous materials, specifically glass or hard plastic. . . " What happened to the common pre-operational inspections and other daily food safety and quality control measures? 
This is not an issue of pathogenic bacteria contamination and evidence of illness may not be immediate. but is lead as significant a concern? How do you see or feel about the statement: “No illnesses have been reported to date” in these recall notices?
“While the U.S. Food and Drug Administration (FDA) has not set a specific limit on lead in spices, there is a limit of 0.1 PPM in candy. The Environmental Protections Agency (EPA) has stated that lead levels of 0.015 PPM in drinking water require treatment. Lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. No illnesses have been reported to date.

Case Study 46 – General Mills Expands Recall
Back in case study 43, the question was asked if more products could have been affected than were initially reported? This is a staple question in every recall exercise, even mock recalls. Given this July 25th announcement, how well would you say General Mills performed with respect to this question?
Included in the announcement in bold lettering is this statement: “Consumers are reminded not to eat uncooked dough or batter made with raw flour”. One would expect then that this warning has been previously communicated to the consumers of these products through the labels or other applicable means. This is at least implicitly (if not explicitly) required in the era of FSMA-HARPC. One wonders then, about how well General Mills is ready to meet FSMA-HARPC given their claims about food safety management provisions (in funds and staff). Granted, FSMA-HARPC enforcement may not yet be fully in effect for General Mills, but that is coming soon enough.
By the way, what is HAACP?

Case Study 45 - Chapel Hill Creamery 
Below are quotes from the recall announcement:
“Health officials have identified recent cases of Salmonella infection in persons who consumed Chapel Hill Creamery products.”
A matching strain of Salmonella has been identified in the milk from the creamery that was used during preparation of the cheese products.
“Portia McKnight, co-founder of the Creamery, saidAlthough there is not yet a definitive link between the CHC cheese and the illnesses, there is enough evidence to implicate the cheese and we are asking customers to not consume these cheeses or use them in food service.’”

What needless contradiction do you see?

Case Study 44: GLOBAL NEWS Video

Case Study 43Cake Mix Recall due to E. Coli O121 
What are the facts?
Brand Name: Betty Crocker Super Moist
Common Name: Cake Mix Rainbow Bit
Size: 432 g
Code(s) on Product: 27AL2017 PV,08JN2017 PV,09JN2017 PV
UPC: 0 65633 46589 3
Having a common name, common UPC but three codes is somewhat understandable but why more than one full month of production that has E. coli contamination in a company that claims as follows:
  • US$13 million food safety spending (more than 10 percent of essential capital investment on average each year for food safety-related projects)
  • 600+ trained quality professionals and 55+ certified quality engineers monitoring food safety worldwide
  • 100 percent of our facilities audited using globally recognized food safety criteria (excluding Yoki)
  • 90 percent of our facilities worldwide audited and/or certified by third parties
  • Across General Mills, we have achieved GFSI certification of 72 percent of our company-owned production facilities - General Mills Food Safety
It could get quite messy if these announcements are thoroughly examined:
Is it possible that more products than the Betty Crocker Super Moist using the affected brands of flour are affected?

Case Study 42:
June 5th Update: Take a look at this CFIA Recall Update and go back to the prior prediction below. This expansion that was predicted may not even be the end of the matter. We'll see if investigations reveal that only the June 5th listed lots are actually affected. I suspect that more products are likely to be affected if the usage trails of equipment, raw materials, work-in-process materials and/or rework are more thoroughly investigated.

Partly Skimmed Chocolate Milk Recall: 
This June 3rd recall notice listed only one lot of product. Watch for the recall to be expanded soon. Listeria is an environmental contaminant. It is very likely that more production batches than has been identified were affected in this instance. Technically, this June 3rd announcement should not have been made with only one batch of product identified. The L. m. detection test turn-around time and the production rate in a dairy operation are also some consideration to take into account in publishing such notices.

Case Study 41:
Have you checked the price of cauliflower in the grocery store lately? Why would sulfite be used in the processing of cauliflower and not declared?

Case Study 40:
Wait a minute! Whom are they trying to fool?

  1. Soy and anchovies do not constitute “an allergen”; they are separate allergens: soy and anchovies.
  2. Reduced Sodium Worcestershire Sauce and Organic Ketchup should not be described as “an ingredient”; they are separate ingredients:
The inaccurate declarations are too obvious to ignore. It is not difficult at all to see that the implications within this recall case reach far beyond the possibility of reactions by allergy sufferers. What appeared to have happened is beyond a simple human error. I’ll have to be convinced that this is not a deliberate attempt to deceive first, in the product preparations involved,  and then in the recall announcement.  

Case Study 39:
Who do those making these kinds of announcements think they are fooling by redundant statements like the one highlighted and crossed out below? Deleting that statement does not take anything away from what consumers need to know about this notice. So why is the statement added, if it is not to temper reactions to the brand in the ever so frequent attempts to protect brands as the central consideration while the protection of consumers is treated as a side consideration or an after-thought?
"Today, Mars Chocolate North America announced a voluntary recall of its DOVE® Chocolate Assortment Snowflakes, 24.0 oz. bag - this is a seasonal item only sold at one major retailer with stores across the U.S.
Item# 10139802 - UPC# 400050521
LOT CODE: 537CG4PA30, 537DG4PA30, 538AG4PA30, 538AM4PA30, 541AG4PA20, 542EM4PA20
This item is a purple 24 oz. bag clearly marked with DOVE® Chocolate Assortment Snowflakes branding on the front of packaging. The code dates and UPC code are located on the back of the packaging on the lower right side. . . “ Read the full Notice

Case Study 38:
For Immediate Release - November 16, 2015 - FDA Orders Recall under Consent Decree
“The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm's continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
These actions are part of the FDA's commitment to patient safety . . .”
This leaves so many questions:
  1. Violations were noted in 2007 and action is being taken only now towards the end of 2015?
  2. “The identified violations could result in an increased risk of infection transmission” Does this statement mean the same thing as resulting in actual infection transmission? If so, how true is the added statement that “These actions are part of the FDA's commitment to patient safety . . .”
Case Study 37:
All at once or not sure which? - Apples with detected presence of Listeria monocytogenes, Salmonella, and/or Enterohemorrhagic E. coli 

Case Study 36:
This recall affected more than one company. Clostridium botulinum is a serious enough concern but I would change the name of one of the companies involved since it resembles the description of another possible cause for recalls.
Case Study 35:
Is this a correct or an incorrect recall classification?
Is this glass in Spaghetti Sauce incident correctly or incorrectly classified as a "Class 2" recallAccording to the  CFIA Recall Guide, a "’Class II’ is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Case Study 34What do you see in this picture?

Case Study 33: Ice Cream Recalls
1. Snoqualmie Gourmet Ice Cream, Inc.: Almost a full year (January 1, 2014 through December 15, 2014) production of ice cream products recalled in this instance -

2. Blue Bell Creameries recall underlining why SSQA way of thinking is a must:
Here is a vivid and painful lesson about proceeding with the false sense of security described in "The Standardized Food Industry Mistake". On what did this company rely? In the February 2015 article by Jim Carper titled “Blue Bell Blossoms with Flavors” you will find this statement:

“Blue Bell emphasizes food safety and employee safety. An in-house quality program is based on third-party certification standards by Silliker Laboratories Group, Chicago" - 
The New York Times reports:
“Inspection Found No Problem at Oklahoma Ice Cream Plant”
In his blog, and with good reason, Attorney Bill Marler said:
“I don’t feel bad for Mr. Kruse and his food safety people.”
What next? Blue Bell may be back and hopefully with a serious look at what gave them the false sense of security that led to the ignoring of some obvious signs (ignored test results) as Bill Marler pointed out in his blog. Other companies are still caught up with the widespread certification sense of security. They are ignoring "The Coming Shift" and are busy taking snap-shots of the scenery while the lava builds underground or are  sleeping certified.

Case Study 32CDC's Recommendation to U.S. Consumers Posted December 19, 2014 9:30 AM ET: “. . . do not eat any commercially produced, prepackaged caramel apples.” At the time of this post, the producer or manufacturer of the products involved was yet to be identified.

Case Study 31Wait, that can’t be true: Traces of date rape drug detected in European baby food? Edmonton Sun Story, December 12, 2014

Case Study 30: General Mills Settles Suit Over '100% Natural' Claim

by Karlene Lukovitz, November 20, 2014, 7:26 AM

Was there or should there be a recall of products mislabeled as “natural” on the grounds of legality?

The report by Karlene includes as follows:

General Mills has stated that it changed the disputed wording even before the lawsuits were filed in 2012. Steve Gardner, CSPI's litigation director, told The Wall Street Journal that CSPI disputes that timing. CSPI has also said that it raised its concerns about the "100% natural" claims with General Mills in private as early as 2005.
Gardner said that the consumer plaintiffs received small payments in the settlement, partly to cover legal costs.
General Mills joins a growing number of food makers that have dropped or changed the wording of natural claims as a result of lawsuits or the threat of such suits. Previous threats or actions by CSPI have resulted in changes in claims used by 7Up, Capri Sun, Crystal Light, Edy's and Dreyer's ice creams, and Izze soft drinks. Pop Chips, Kashi and Trader Joe's have also agreed to settle similar cases without admitting wrongdoing.
CSPI said that the latest settlement, with General Mills, should help "nudge the marketplace, otherwise awash in varyingly flimsy 'natural' claims, in the right direction."
"CSPI" stands for: Center for Science in the Public Interest.

Natural product claims may not pose immediate health concerns to a majority of people. Only a few individuals have been known to react to certain artificial food components such as colors, flavor enhancers, etc. Although, the level of concern about food additives appears to be low, there is a general recognition that some health issues may exist hence the enforcement regulated levels by most regulatory agencies. The World Health Organization also provides the safety evaluation of certain food additivesOn the basis of the forgoing examination of possible health concerns, was there or should there be a recall of products mislabeled as “natural” on the grounds of health concerns?

Case Study 29 - Uneviscerated Dried Roach Recalled.
No, this is not cockroah; it is fish. The sale of uneviscerated processed fish is prohibited under New York State Agriculture and Markets regulations. Who would ordinarily permit the sale of such a product? 

Case Study 28 - Another Peanut Butter Recall in 2014?
Has the peanut butter and similar product industry learned anything from what happened to two of its big players in the past because of Salmonella contamination?

Case Study 27 - Tattoos have recently been hit:
 According to the recall notification on July 11, 2014, the identified company is “ . . . . recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. . .”  FDA Release -

Case Study 26: 
Bill identifies pathogens associated with serious illness or death or that are resistant to two or more critically important antibiotics for human medicine.

"Bill Would Strengthen Existing Food Safety Laws to Ensure USDA Knows It Can Recall Products Contaminated with Dangerous Pathogens, Including Antibiotic Resistant Bacteria"

Case Study 25: Recall due to “unsuitable ingredients”
What is the most likely cause?

Case Study 24: A Voluntary Cheese Product Recall
What is the most likely cause?

Case Study 23:Close to a ton of Sliced Smoked Atlantic Salmon recalled due to possiblecontamination of Listeria monocytogenes.

What do you see as the purpose of the following statement in the announcement?

A single lot of 4oz Vita Classic Premium Sliced Smoked Atlantic Salmon packages is the subject of this public announcement and recall as the result of one package of salmon that tested positive for Listeria monocytogenes by the Florida Department of Agriculture and Consumer Services.

Case Study 22: Food Service Plates - Recall of Appetizer Plates Due to Cadmium and Lead Levels:

Case Study 20
A reasonably well managed recall situation if an expanded scope is not announced at a later date. However, these questions come to mind: 
What circumstances could lead to this kind of a misbranding error over a 2-day (96,000 pounds) run of Hot Dog products?
What measures (QC inspections , etc.) could have prevented it?
MissouriFirm Recalls Hot Dog Products Due To Misbranding and Undeclared Allergens -

Case Study 19

This recall affects quite a wide scope (US and Canada). I wonder if the affected manufacturing site has a food safety / HACCP program in place and whether the hazard analysis identified Listeria monocytogenes. Ice cream certainly falls under the “high risk” category that requires tight hazard controls.

Case Study 18: What and how many questions does this recall notice raise?

Recall Summary:
Roughly over 1 million pouches of freeze-dried snacks (sliced fruit) are affected by this recall. The manufacturing company is reportedly committed to strict quality control, with experience processing under SQF(Level 2) and a variety of regulatory requirements, including USDA and FDA. The company is also said to have the ability to freeze dry over 400 different food and pharmaceutical products.
The notice indicated that the company issued the recall after determining the product has the potential to be contaminated with Salmonella but no confirmed cases of Salmonella poisoning from consumption of this product have been reported.
The affected product may have been distributed to: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and Puerto Rico. . . .
Affected products: Best Before Date: FEB 14 2015 - MAR 11 2015 

Case Study 17: Recall & GFSI Certification
No operation is exempt from recalls simply because it is world class and has GFSI certification:
Lucerne Foods – Quality Assurance & GFSI (BRC) Certification

Case Study 16: Would you say this is a voluntary recall, or is it compelled due to reported reactions?
View the recall statement by the company:

Case Study 15: It’s a small world after all: Eye Drops Made in Vietnam, identified with a “V” in the lot number on the bottom panel of the carton, used in the USA

Case Study 14: Poisoned Soda Alert in Greece and the Obvious Question: Are other countries affected?

Case Study 13:
November 11, 2013, 6:36 AM - CBS News
How many people could 90 Tons of ready to eat salads and wrapped products potentially affect?
Further expansion of previous recalls of fresh cut vegetables, ready-to-eat salads, slaws, dips and spreads – take a look at the FDA List:

Are killer salads the next big thing out of the US and Canada – Case studies 10, 11 & 12?

Are all of these recall notices related to a common source of the problem? A good traceability system within the affected facilities should provide the answer to this question.
Thankfully, “NO illnesses have been reported to date.” BUT HOW METICULOUSLY HAS THIS BEEN INVESTIGATED?
Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems. Healthy people may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea  – AND LOST DAYS FROM WORK. Listeria infection can cause miscarriages and stillbirths among pregnant woman – WHO USUALLY WANT TO EAT SALADS BECAUSE THEY ARE DEEMED TO BE “HEALTHY” FOOD.


United States - USDA

11/01/2013 05:53 PM EDT
Following the Reser’s Fine Foods (“Reser’s”) recall where select Reser’s products were recalled due to the potential of being contaminated with Listeria monocytogenes, Dutch Treat Salads, LLC, of Zeeland, MI, is voluntarily recalling one product, Mexicali Dip, that contains one ingredient recalled by Reser’s.
11/01/2013 04:07 PM EDT
Winn-Dixie today announced an immediate recall in all Winn-Dixie stores of the Taylor Farms Broccoli Crunch Salad sold in the full-service case in the deli department. According to the U.S. Food and Drug Administration, the reason for the recall is the potential that the product may be contaminated with Listeria monocytogenes. The recall is part of a larger recall issued by Taylor Farms Tennessee, Inc. and Taylor Farms Maryland, Inc. as a result of a recall of Reser's Fine Food Inc. products.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
11/01/2013 04:10 PM EDT
Winn-Dixie today announced an immediate recall of the Taylor Farms Spinach Antipasta Salad in all Winn-Dixie stores. This recall is an expansion of an earlier recall announced by Reser's Fine Foods, Inc.
11/04/2013 12:33 PM EST
Ghiringhelli Specialty Foods of Vallejo, California is voluntarily recalling one specific lot of Trader Giotto’s Caesar Salad (SKU 05161) with a "Use By 11/03" date, because it may not list wheat, soy and fish (anchovy) in the ingredients. People who have an allergy or severe sensitivity to wheat, soy and/or anchovy run the risk of serious or life-threatening allergic reaction if they consume these products.
11/04/2013 01:07 PM EST
Reser’s Fine Foods, Inc. of Beaverton, Oregon is voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems.
11/04/2013 01:32 PM EST
October 30, 2013 - Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products included in the expanded recall were produced between the dates of September 5, 2013 through October 16, 2013.

Canada – CFIA
November 3, 2013

Case Study 12
USDA EST. 17256 or Est. P-17256 - So highly inspected and audited  – USDA, HACCP and SQF  - yet so lowly treated by several recalls and expanded recalls
Search for “Garden-Fresh”: Facility at 726 South 12th Street, Milwaukee, WI 53204-1211, Phone (414) 645-1000  to view SQF Certificate with - E – Excellent rating and Expiration Dateof Nov 25, 2013.

Case Study 11: 

Case Study 10: 
Reality speaks much louder than exaggerated promises to ensure food safety: 
The Company’s Food Safety Promise - "Ushering In a New Era of Food Safety" - Food Safety Tab.
You can do a public search for the Third Party certification status of this company here Certified Suppliers – Public Search. As using the full company name does not appear to be working for the search, you may need to simply type the first 5 letters of the company’s name in the "Site Name' field at the bottom of the page to get the search to work.
The reality that followed the Food Safety Promise:
CFIA (Canada Recalls)
FDA & USDA (U.S. Recalls)
FOR IMMEDIATE RELEASE - October 22, 2013 - approximately 109,000 cases of refrigerated ready-to-eat products may be contaminated with Listeria monocytogenes.
WASHINGTON, Oct. 22, 2013 – approximately 22,800 pounds of chicken, ham and beef products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Case Study 9:
Another Real-life Case of Botched Traceability:
Updated Health Hazard Alert - Certain Uncooked Lean Ground Beef may contain E. coli O157:H7 bacteria Ottawa, October 20, 2013 – “The public warning issued on October 8, 2013 has been updated to include an additional product.”
Why did it take this long to expand the scope of affected products? In the background of this and the related earlier recall is the CFIA requirement for pathogen testing in raw meats – Modified 2013-06-07:

Case Study 8:
FOR IMMEDIATE RELEASE - October 4, 2013If no other product with a shelf life date outside of the identified shelf life span is later implicated, this recall notice shows a good identification of problem, cause and scope of affected products.

Case Study 7:

 Even big companies find it difficult to recover from hazardous product recalls:

October 2012: Sunland voluntarily recalled all of its products due to Salmonella contamination.

November 2012: The Food and Drug Administration suspended the Sunland’s food facility registration.

May 2013: Sunland received authorization from the F.D.A. to resume full operations.

October 9, 2013: Despite resuming operations, the company said ongoing financial and liquidity challenges made it necessary for management to file for bankruptcy: Sunland, Inc. files for bankruptcy protection 

Case Study 6:
A barrage of recalls notices in Canada & US within two weeks (September 30 – October 8, 2013):
October 8, 2013 - frozen beef burgers - E. coli O157:H7 
October 5, 2013 - cheesy macaroni salad – Listeria 
October 4, 2013 - Pizza Pack - Listeria 
October 2, 2013 - Halloween Kiss Candies – Metal 
October 2, 2013 - Beef Burgers -  E. coli O157:H7 
September 30, 2013 -  A Fisheries Company  -  ALL smoked products from all lots and codes, various sizes, in vacuum packages because the products may not have been properly cooked and have the potential to be contaminated with Clostridium botulinum 

Case Study 5:
 Uncertainty about the national distribution indicates a small gap in the traceability information.

Case Study 4:
Here is a recall announcement that is infuriating on different levels: FOR IMMEDIATE RELEASE - Sept. 13, 2013
The expanded scope was delayed for more than one month from July 12, 2013 to August 29, 2013 – a clear evidence of a failed traceability system
The announcement states: “no received reports of any adverse events associated with this issue for this lot”. - This is infuriating. The reporting of adverse events is likely to be conveniently hushed under the circumstances in which the affected Bupivacaine HCl Injection lots are most likely to be used.
The last paragraph in the announcement boasts of the affected company’s leading role in the industry and the company is said to be “positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs”. – This is an out-of-place boasting since it follows a recall announcement.

Case Study 3:
More Recall Updates with statements that reveal more than might have been intended by the affected supplier: 
FOR IMMEDIATE RELEASE - September 3, 2013
The following statement in this recall can be annoying to consumers:
“The following is a revised list of product lots that are included in the voluntary recall; please disregard the original list found in the September 1, 2013 recall press release.”
Why were the affected products not correctly listed in the first instance? The statement reveals the lack of a properly developed and implemented traceability program and controls.  You may view the updated press release here:

Case Study 2:
Here is another interesting recall situation:

“. . . in a recent inspection . . . FDA investigators observed methods used . . .  to assess sterility and other qualities (e.g., strength and stability) may have resulted in  . . .  inaccurate sterility test results . . . If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. . .”

The manufacturer may have done the right thing but it appears to rely heavily on testing for its confidence in the safety and potency of its manufactured medications. The product design and manufacturing controls should normally have been the bases for this confidence. Testing only verifies the safety and potency.
On the other hand, how many other manufacturers did this one lab affect? The press release does not mention any other pharmaceutical company that may have been affected by the inaccurate testing methods used by the laboratory in question. It makes one wonder if due diligence has been exercised by all parties involved in this instance to provide adequate safeguard for consumers. Should the laboratory be notifying other pharmaceutical companies that it serves and should these companies be issuing recalls as well? It also begs the question about the reliability of the accreditation program under which this laboratory operates.
Inexcusable Late Reaction
The following recent recall announcements clearly show the infuriating tardiness in some recall situations. If on August 26, I raised the question about other possibly affected companies, why were these recent announcements delayed for more than one week?
FOR IMMEDIATE RELEASE – September 9, 2013 - 
FOR IMMEDIATE RELEASE –September 10, 2013 -
How many more of these kinds of “new” notices will we see?
Affected Companies Update:
1. Another pharmaceutical company has initiated a recall due to the the inaccurate testing methods used by the contracted laboratory -

Case Study 1:
After reading the announcement and noting how the issue was discovered, the intended use of the product, the target users, the label information, etc., do you suspect that this recall was due to: unexpected system failure, minor human error, a deliberate action that may or may not have been sanctioned by the company, or any other cause?

You are invited to provide comments. The following radio interview and posts may also be of interest to you:
Designing quality and safety into food products -

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