Category: recalls

Novartis Gives Consumers Excedrin Headache

“Your Quality Unit has failed in the responsibility and authority to monitor Quality Systems designed to assure the quality of drug products manufactured and packaged at your firm.”

– FDA to Novartis Consumer Health (Lincoln, Nebraska), July 8, 2011

On July 8, 2011, FDA completed an inspection of Novartis Consumer Health (Lincoln, Nebraska), and handed the company a report (Form 483) listing 13 separate “Observations” relating to deficiencies in Novartis’ quality assurance and complaint handling systems.

About one month later, Giant® Food Stores notified its customers that Novartis had recalled Excedrin Extra Strength Caplets, 100-count (Lot #10068948; Expiration date March 31, 2010), “as a result of instances of product mix-ups found in the lot” (posted on eFoodAlert September 7, 2011).

On November 1, 2011, Giant® Food Stores warned its customers of another Novartis recall – Excedrin – Pain Reliever Acetaminophen Adult, 100 CO (Lot #10087530; Expiration date 3/31/2013). Again, the recall was due to product mix-up occurrences in the lot. That same day, Food City posted a recall notice for three Novartis products, including Excedrin Extra Strength Caplets 24 count, Excedrin Migraine Caplets 24 count, and Excedrin Floorstand ES Migraine with $1 IRC. More retailers chimed in the following day, and a consolidated list of recalled lots was provided on eFoodAlert’s Recalls and Alerts: November 2, 2011.

Today (January 8, 2012), in an unusual Sunday announcement, Novartis Consumer Health, Inc. issued a News Release detailing the recall of “…all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”

Am I being silly, or is it just possible that FDA’s posting on January 5th of the July 8, 2011 Novartis Inspectional “Observations” Report might be somehow tied into this sudden decision by Novartis to go public?

Here are just a few excerpts from the report. These are direct quotations. Read them and decide for yourself.

  • You have failed to open deviation investigations into numerous “critical” consumer complaints of foreign products found inside the drug products manufactured at your firm.
  • You have failed to adequately investigate 166 complaint instances of foreign tablets in your drug products since 2009.
  • You have failed to extend investigations to all batches of product potentially affected by a problem.
  • You have received numerous consumer complaints which were not submitted to the FDA as required by your firm’s procedures.
  • Your Quality Assurance review of critical foreign tablet complaint investigations (Technical Complaint Investigation Reports) is not occurring in a timely manner… There are approximately 138 reports that took over 100 days to review.
  • You have failed to identify the root cause of customer complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009.
  • Your Unplanned Deviation Reports are deficient in that conclusions drawn are not supported by the evidence in the reports.
  • Your Quality Assurance Unit has consistently failed to review critical complaints for drug products manufactured and packaged at your facility. For example [for 2011], 223 critical complaints have not been properly reviewed out of 223 critical complaints received by your firm… Also, your Quality Assurance review of critical complaints ceased in mid-October 2010. This deficiency was unnoticed by your Quality Unit until this FDA inspection.

The entire report is 13 pages long. It details lapses in procedure, in judgment, and in training.

In addition to the recall, Novartis advises that its Lincoln, NE facility “…has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.”

I have to ask – WHAT TOOK SO LONG?

Novartis has promised to have a dedicated web page (www.novartisOTC.com) in operation by January 9th to provide consumers with detailed information on its newly announced recall. The complete list of recalled products follows:

  • Bufferin® Extra Strength Tablets 130CT: UPC 300672065131
  • Bufferin® Extra Strength Tablets 39CT: UPC 300672065391
  • Bufferin® Low Dose Tablets 130CT: UPC 300676424132
  • Bufferin® Regular Strength Tablets 130CT: UPC 300672063137
  • Excedrin® Back & Body Caplets 100CT Account Specific: UPC
  • 300676238920
  • Excedrin® Back & Body Caplets 100CT Account Specific No Carton: UPC 300676238944
  • Excedrin® Back & Body Caplets 100CT New Label: UPC 300676238913
  • Excedrin® Back & Body Caplets 24CT New Label: UPC
  • 300676238241
  • Excedrin® Back & Body Caplets 50CT New Label: UPC
  • 300676238500
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000927
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000941
  • Excedrin® Extra Strength Caplets 100CT Account Specific: UPC 300672000910
  • Excedrin® Extra Strength Caplets 100CT: UPC 300672000910
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack: UPC 300672000835
  • Excedrin® Extra Strength Caplets 125CT Bonus Pack Account Specific: UPC 300672000842
  • Excedrin® Extra Strength Caplets 125CT New Carton: UPC 300672000866
  • Excedrin® Extra Strength Caplets 24+6CT Bonus Pack: UPC 300672000309
  • Excedrin® Extra Strength Caplets 24CT: UPC 300672000248
  • Excedrin® Extra Strength Caplets 24CT New Label: UPC 300672000248
  • Excedrin® Extra Strength Caplets 250CT No Carton: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT No Carton New Label: UPC 300672000071
  • Excedrin® Extra Strength Caplets 250CT Special Inner: UPC 300672000774
  • Excedrin® Extra Strength Caplets 250CT New Label: UPC 300672000774
  • Excedrin® Extra Strength Caplets 300CT Bonus Pack: UPC 300672000552
  • Excedrin® Extra Strength Caplets 50CT New Label: UPC 300672000507
  • Excedrin® Extra Strength Caplets 50S: UPC 300672000507
  • Excedrin® Extra Strength Express Gel Caps 20CT New Label: UPC 300676270203
  • Excedrin® Extra Strength Express Gel Caps 40CT New Label: UPC 300676270401
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270814
  • Excedrin® Extra Strength Express Gel Caps 80CT: UPC 300676270807
  • Excedrin® Extra Strength Express Gel Caps 80CT Account Specific: UPC 300676270944
  • Excedrin® Extra Strength Gel Tablets 24CT: UPC 300672021243
  • Excedrin® Extra Strength Tablets 100CT Special Inner: UPC
  • 300672030917
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030931
  • Excedrin® Extra Strength Tablets 100CT Account Specific: UPC 300672030948
  • Excedrin® Extra Strength Tablets 100CT New Label: UPC 300672030917
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack: UPC 300672030832
  • Excedrin® Extra Strength Tablets 125CT Bonus Pack New Carton: UPC 300672030863
  • Excedrin® Extra Strength Tablets 200CT New Label: UPC 300672030924
  • Excedrin® Extra Strength Tablets 24+6CT Bonus Pack: UPC 300672030306
  • Excedrin® Extra Strength Tablets 24CT: UPC 300672030245
  • Excedrin® Extra Strength Tablets 24CT New Label: UPC 300672030245
  • Excedrin® Extra Strength Tablets 250+50CT Bonus Pack: UPC 300672030573
  • Excedrin® Extra Strength Tablets 250CT No Carton: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT No Carton New Label: UPC 300672030078
  • Excedrin® Extra Strength Tablets 250CT Special Inners: UPC 300672030771
  • Excedrin® Extra Strength Tablets 250CT New Label: UPC 300672030771
  • Excedrin® Extra Strength Tablets 300CT New Carton: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT Club Tray: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300CT New Label: UPC 300672030337
  • Excedrin® Extra Strength Tablets 300S: UPC 300672030337
  • Excedrin® Extra Strength Tablets 50CT: UPC 300672030504
  • Excedrin® Extra Strength Tablets 50CT New Label: UPC 300672030504
  • Excedrin® Extra Strength Tablets 8CT: UPC 300672030085
  • Excedrin® Extra Strength Tablets 8CT New Label: UPC 300672030085
  • Excedrin® Migraine Express Gel Caplets 20CT New Label: UPC 300676341200
  • Excedrin® Migraine Caplets 100CT: UPC 300672039910
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific No Carton: UPC 300672039941
  • Excedrin® Migraine Caplets 100CT Account Specific: UPC 300672043917
  • Excedrin® Migraine Caplets 100CT New Label: UPC 300672039910
  • Excedrin® Migraine Caplets 125CT Bonus Pack No Carton: UPC 300672039842
  • Excedrin® Migraine Caplets 125CT Bonus Pack New Carton: UPC 300672039866
  • Excedrin® Migraine Caplets 125CT Bonus Pack: UPC 300672039835
  • Excedrin® Migraine Caplets 200CT New Label: UPC 300672039927
  • Excedrin® Migraine Caplets 24+6CT Bonus Pack: UPC 300672039309
  • Excedrin® Migraine Caplets 24CT: UPC 300672039248
  • Excedrin® Migraine Caplets 24CT New Label: UPC 300672039248
  • Excedrin® Migraine Caplets 250+50CT Bonus Pack: UPC 300672039576
  • Excedrin® Migraine Caplets 250CT No Carton: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT No Carton New Label: UPC 300672039071
  • Excedrin® Migraine Caplets 250CT Special Inners: UPC 300672039774
  • Excedrin® Migraine Caplets 250CT New Label: UPC 300672039774
  • Excedrin® Migraine Caplets 300CT: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Carton: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT New Label: UPC 300672039330
  • Excedrin® Migraine Caplets 300CT Club Tray: UPC 300672039330
  • Excedrin® Migraine Caplets 50CT New Label: UPC 300672039507
  • Excedrin® Migraine Caplets 50CT: UPC 300672039507
  • Excedrin® Migraine Caplets 8CT New Label: UPC 300672039088
  • Excedrin® Migraine Gel Tablets 160CT: UPC 300672035165
  • Excedrin® Migraine Gel Tablets 100CT Special Inner: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT New Label: UPC 300672035912
  • Excedrin® Migraine Gel Tablets 100CT Account Specific: UPC 300672044914
  • Excedrin® Migraine Gel Tablets 24CT – New Label: UPC 300672035240
  • Excedrin® Migraine Gel Tablets 2X50CT: UPC 300672035936
  • Excedrin® Migraine Gel Tablets 50CT New Label: UPC 300672035509
  • Excedrin® Migraine Tablets 100CT Special Inner: UPC 300672037916
  • Excedrin® Migraine Tablets 100CT New Label: UPC 300672037916
  • Excedrin® Migraine Tablets 125CT Bonus Pack: UPC 300672037831
  • Excedrin® Migraine Tablets 24+6CT Bonus Pack: UPC 300672037305
  • Excedrin® Migraine Tablets 24CT: UPC 300672037244
  • Excedrin® Migraine Tablets 24CT New Label: UPC 300672037244
  • Excedrin® Migraine Tablets 250CT Special Inner: UPC 300672037770
  • Excedrin® Migraine Tablets 250CT New Label: UPC 300672037770
  • Excedrin® Migraine Tablets 50CT: UPC 300672037503
  • Excedrin® Migraine Tablets 50CT New Label: UPC 300672037503
  • Excedrin® PM Caplets 100CT New Label: UPC 300672055910
  • Excedrin® PM Caplets 125CT Bonus Pack New Carton: UPC 300672055866
  • Excedrin® PM Caplets 24CT New Label: UPC 300672055248
  • Excedrin® PM Caplets 50CT New Label: UPC 300672055507
  • Excedrin® PM Express Gel Caplets 20CT: UPC 300676405209
  • Excedrin® PM Express Gel Caplets 80CT Account Specific: UPC 300676405810
  • Excedrin® PM Express Gel Caplets 80CT No Carton: UPC 300676409801
  • Excedrin® PM Express Gel Caplets 80CT New Label: UPC 300676405803
  • Excedrin® PM Tablets 100CT Account Specific: UPC 300672053923
  • Excedrin® PM Tablets 100CT Account Specific No Carton: UPC 300672053947
  • Excedrin® PM Tablets 100CT New Label: UPC 300672053916
  • Excedrin® PM Tablets 125CT Bonus Pack: UPC 300672053831
  • Excedrin® PM Tablets 24+6CT Bonus Pack: UPC 300672053305
  • Excedrin® PM Tablets 24CT New Label: UPC 300672053244
  • Excedrin® PM Tablets 50CT New Label: UPC 300672053503
  • Excedrin® PM Tablets 8CT New Label: UPC 300672053084
  • Excedrin® Sinus Headache Caplets 24CT New Label: UPC 300672062246
  • Excedrin® Tension Headache Caplets 100CT Special Inner: UPC 300672045911
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific No Carton New Label: UPC 300672045942
  • Excedrin® Tension Headache Caplets 100CT Account Specific: UPC 300672045959
  • Excedrin® Tension Headache Caplets 100CT New Label: UPC 300672045911
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack: UPC 300672045836
  • Excedrin® Tension Headache Caplets 125CT Bonus Pack No Carton: UPC 300672045843
  • Excedrin® Tension Headache Caplets 24+6CT Bonus Pack: UPC 300672045300
  • Excedrin® Tension Headache Caplets 24CT Special Inner: UPC 300672045249
  • Excedrin® Tension Headache Caplets 24CT New Label: UPC 300672045249
  • Excedrin® Tension Headache Caplets 250CT: UPC 300672045775
  • Excedrin® Tension Headache Caplets 250CT No Carton: UPC 300672045072
  • Excedrin® Tension Headache Caplets 50CT Special Inner: UPC 300672045508
  • Excedrin® Tension Headache Caplets 50CT New Label: UPC 300672045508
  • Excedrin® Tension Headache Express Gel Caplets 20CT: UPC 300676272207
  • Excedrin® Tension Headache Express Gel Caplets 40CT: UPC 300676272405
  • Excedrin® Tension Headache Express Gel Caplets 80CT Account Specific: UPC 300676272948
  • Excedrin® Tension Headache Express Gel Caplets 80CT: UPC 300676272801
  • Excedrin® Tension Headache Gel Tablets 24CT New Label: UPC 300672050243
  • Gas-X® Prevention® Caplets 20CT: UPC 300433005208
  • Gas-X® Prevention® Caplets 50CT: UPC 300433005505
  • NoDoz® Maximum Strength Caplets 16CT: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 16CT New Graphic: UPC 300672070166
  • NoDoz® Maximum Strength Caplets 36CT: UPC 300672070364
  • NoDoz® Maximum Strength Caplets 36CT New Graphic: UPC
  • 300672070364
  • NoDoz® Maximum Strength Caplets 60CT: UPC 300672070609
  • NoDoz® Maximum Strength Caplets 60CT New Graphic: UPC 300672070609

The recall encompasses all production lots of these products distributed in the USA. In addition, two of the recalled products – Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets – were exported to Canada. Following is a list of retail supermarkets and pharmacies in the USA and Canada who stocked the recalled products (updated January 17, 2012):

  • Acme: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Albertsons: Excedrin, Bufferin, NoDoz & Gas-X Prevention
  • Big Y: Excedrin and Gas-X
  • Buehler’s Fresh Foods: Excedrin, Bufferin, GasX and NoDoz
  • Copps: All lot codes of Excedrin, Bufferin, No-Doze and Gas-X Prevention
  • Costco: Excedrin products (Costco Item ##720393,#672030, #146557, #618236, and #6189) sold on or after January 8, 2009
  • Costco Canada: Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (All expiration dates up to and including December 20, 2014)
  • D&W Fresh Market: Bufferin and Excedrin products
  • Family Fare Supermarkets: Bufferin and Excedrin products
  • Food City: Assorted Excedrin, No Doz, Bufferin & Gas-X Items
  • Giant Eagle: Bufferin, Excedrin, Gas-X and NoDoz
  • Giant® Food Stores: Excedrin, Bufferin, No Doz & Gas-X
  • The Kroger Company (including Kroger, King Soopers, City Market, Jay C, Dillons, Baker’s Gerbes, Fry’s, Food4Less, Food4Less Fremont, FoodsCo, Ralphs, Fred Meyer, Smith’s and QFC stores): Bufferin, Excedrin, No Doz and Gas-X
  • Glen’s: Bufferin and Excedrin products
  • Glen’s Fresh Market: Bufferin and Excedrin products
  • H-E-B: Bufferin, Excedrin, Gas-X Prevention and NoDoz
  • Mariano’s Fresh Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Metro Market: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Pick ‘n Save: All lot codes of Excedrin, Bufferin, No-Doze, Gas-X
  • Price Chopper: Excedrin, Bufferin, GasX, No Doz
  • Publix: Excedrin, Gas-X, Bufferin and No-Doz
  • Rainbow: All lots of Excedrin, Bufferin, No-Doze, Gas-X
  • Rite Aid: Bufferin, Excedrin, Gas-X Prevention and NoDoz products
  • Schnucks: (including Schnucks, Logli and Hilander stores): Excedrin, Bufferin, NoDoz and Gas-X Prevention
  • ShopRite: Bufferin, Excedrin, NoDoz and Gas-X Prevention products
  • Spartan: Bufferin and Excedrin products
  • Target: Excedrin and Gas-X Prevention products
  • Top Food & Drug: Excedrin and Bufferin products
  • Valu Land: Bufferin and Excedrin products
  • VG’s Fresh Market: Bufferin and Excedrin products
  • VG’s Grocery: Bufferin and Excedrin products
  • Walgreens: Provides link to recall notice on FDA site
  • Walmart (including Walmart and Sam’s Club stores): Excedrin, N0Doz, Bufferin and Gas-X Prevention products
  • Wegmans: Bufferin, Excedrin, Gas-X Prevention and NoDoz products

Hannaford Hamburger US Salmonella Outbreak – An Update

Updated December 22, 2011

On December 20th, CDC reported that 16 people in Hawaii (1), Kentucky (1), Massachusetts (1), Maine (4), New Hampshire (4), New York (4), and Vermont (1) have been infected with the relatively uncommon outbreak strain of Salmonella Typhimurium. Illnesses began on or after October 8, 2011, with the most recent illness onset reported on or about December 3rd.

Most of the illnesses are linked to the consumption of store-ground hamburger meat purchased from Hannaford supermarkets. Hannaford is a regional chain located in the northeast USA, with stores throughout Maine, Massachusetts, New Hampshire, New York and Vermont. The implicated ground beef packages were purchased between October 12th and November 20th.

Given the geographic location of Hannaford’s stores, it’s logical that the Northeastern states should bear the brunt of this outbreak. But what about the cases in Kentucky and Hawaii?

I checked with the departments of health for both states. Other than the genetic similarity between the strains of Salmonella Typhimurium recovered from outbreak patients, there is nothing that connects either the Hawaii or the Kentucky victim to this outbreak. Neither one reported traveling to the US Northeast prior to becoming ill. And, while the Kentucky case is still being investigated, neither victim reported any obvious link to the outbreak, such as consuming ground beef in the week before becoming ill.

Epidemiologists have nightmares like this!

Of course, the explanation may be very simple. PFGE, the genetic profiling used as a first stage “genetic fingerprint” in outbreak investigations is not infallible. CDC has been working with a second genetic profiling tool, which has, in some recent outbreaks, found that a few apparently connected illnesses actually were due to different strains of the same microbe. It’s also possible that some other common link will be found, or that the Kentucky and Hawaii cases will prove to be simply coincidental.

Regardless of the explanation for the Kentucky and Hawaii oddball cases, CDC offers the following reminders to consumers:

  • Consumers should check their homes, including their freezers, for recalled ground beef products and not eat them; restaurant and food service operators should not serve it. Consumers with questions about recalled ground beef products may contact Hannaford’s Customer Information Center, 8 a.m. to 8 p.m. at telephone number (800) 213-9040, and choose option 6.
  • Wash hands, kitchen work surfaces, and utensils with soap and water immediately after they have been in contact with raw meat or poultry, including frozen and fresh ground beef. Then, disinfect the food contact surfaces using a freshly prepared solution of 1 tablespoon unscented liquid chlorine bleach to 1 gallon of water.
  • Cook ground beef thoroughly. Ground beef dishes should always be cooked to 160°F internal temperature as measured with a food thermometer; leftovers also should be reheated to 160°F. The color of cooked ground beef is not an indicator that product has been safely cooked. Only by using a food thermometer can one accurately determine that ground beef has reached a safe minimum internal temperature of 160°F throughout the product. Ground beef can remain pink even after cooking to a safe minimum internal temperature of 160°F. Be particularly careful with foods prepared for infants, older adults, and persons with impaired immune systems. For more information, please visit FoodSafety.gov.
  • If served undercooked ground beef in a restaurant, send it back to the kitchen for further cooking.
  • Avoid cross-contaminating other foods. Uncooked meats and ground beef should be kept separate from produce, cooked foods, and ready-to-eat foods. Do not wash raw meat or poultry before cooking because splashing water can spread any pathogens present on raw meat surfaces to other kitchen surfaces. Hands, cutting boards, counters, knives, and other utensils should be washed thoroughly after touching uncooked foods. Hands should be washed before handling food, and between handling different food items.
  • Refrigerate raw and cooked meat and poultry within 2 hours after purchase (1 hour if temperatures exceed 90°F). Refrigerate cooked meat and poultry within 2 hours after cooking. Refrigerators should be set to maintain a temperature of 40°F or below.
  • Persons who think they might have become ill from eating possibly contaminated ground beef should consult their health care providers. Infants, older adults, and persons with impaired immune systems are more likely than others to develop severe illness.

Original Story (posted December 16, 2011)

Fourteen people in the US northeast have been infected with a strain of antibiotic-resistant Salmonella Typhimurium. Eleven of the 14 victims reported having eaten ground beef; in ten cases, the beef was purchased at a Hannaford store. Seven of the 14 victims (50%) were hospitalized.

Three illnesses were reported in New Hampshire. Other outbreak victims are from Maine (4), New York State (4) and Vermont (1). Three of the four New York State victims were among the seven who were hospitalized.

The outbreak has been traced epidemiologically to fresh in-store ground beef prepared in and purchased at Hannaford stores in Maine, New York, New Hampshire and Vermont between October 12 and November 20, 2011. The 85% ground beef was the most common variety associated with the outbreak.

Hannaford has recalled the following ground beef products (all package sizes) bearing Sell-by dates of Dec. 17, 2011 or earlier that were sold at the supermarket’s stores throughout Maine, Massachusetts, New Hampshire, New York and Vermont:

  • 73% Hannaford Regular Ground Beef
  • 75% Hannaford Regular Ground Beef
  • 80% Hannaford Regular Ground Beef
  • 85% Hannaford Regular Ground Beef
  • 90% Hannaford Regular Ground Beef
  • 80% Taste of Inspirations Angus Ground Beef
  • 85% Taste of Inspirations Angus Ground Beef
  • 90% Taste of Inspirations Angus Ground Beef
  • 85% Nature’s Place Ground Beef
  • 90% Nature’s Place Ground Beef

USDA’s Food Safety and Inspection Service (FSIS) has not been able to identify the suppliers who furnished Hannaford with the raw meat that was used to prepare the recalled ground beef, due to what the agency described as the retailer’s “limited records.” The possibility exists that raw beef contaminated with the Salmonella outbreak strain may also have been supplied to other retailers in the region.

Consumers who purchased ground beef from a Hannaford Supermarket should check their refrigerators and freezers for the recalled product. Hannaford is urging its customers to discard or return any packages of ground beef bearing a sell-by date of Dec. 17, 2011 or earlier. Anyone experiencing symptoms of salmonellosis should seek medical attention.

FSIS reminds consumers to “safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160° F.”

FDA Issues Warning Letter to CooperVision, Inc.

I have been reporting on problems with CooperVision’s contact lenses – and their drawn-out recall process – since August 23, 2011. More than 50 eFoodAlert readers have responded to my articles by describing their own unhappy experiences with several of CooperVision’s contact lens brands.

Despite all of the adverse reactions reported to FDA and those posted on eFoodAlert, CooperVision has elected NOT to recall any contact lenses other than the Avaira® Toric and Avaira® Sphere brands (and the related brand names used in various international markets).

Earlier today, FDA released a Warning Letter (Warning Letter NYK-2012-4) that the agency issued to CooperVision, Inc. on December 5, 2011. The Warning Letter resulted from an inspection of the company’s West Henrietta, NY facility and the apparent inadequacy of CooperVision’s response to significant violations noted by the FDA inspectors during their review of the company’s operations.

Following are excerpts from the FDA Warning Letter, which was addressed to Mr. John Weber, President, CooperVision, Inc (I have added emphasis of certain items in boldface).

“Dear Mr. Weber:

During an inspection of your firm located in West Henrietta, New York conducted October 14, 2011 through October 24, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device labeler, packer and distributer of daily soft wear contact lenses and extended wear soft contact lenses, Class II and Class III medical devices respectively, under the Biomedics, Proclear, Frequency, Biofinity, Avaira & Hydron names. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of Section 501 (h) of the Act (21 U.S.C. § 351 (h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System(QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Bonnie Tsymbal, Director of Regulatory Affairs and Quality Assurance, dated November 3, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to Mr. James Della Valle, Vice President of Distribution. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to adequately validate a process according to established procedures whose results cannot be fully verified by subsequent inspection as required by 21 C.F.R. § 820.75(a)…

2. Failure to establish procedures for finished device acceptance as required by 21 C.F.R. § 820.80(d). Specifically, your firm has not established procedures for finished device acceptance for labeling operations for any of your products…

3. Failure to establish procedures for device history records (DHR’s) as required by 21 C.F.R. § 820.184. Specifically, your firm has not established and maintained procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of this part (21 C.F.R. § 820.184)…

4. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, including failure to adequately identify the actions needed to correct and prevent recurrence of nonconforming product an other quality problems, as required by 21 C.F.R. § 820.100(a)(3). Your firm did not implement its procedure, Corrective and Preventive Action, SOP Number QAP082, Revision Number 11, for initiating a CAPA when required by its Risk Assessment Matrix. If the Risk Assessment number falls into the Red categories on the Risk Assessment Matrix, a CAPA must be raised. For its labeling operations, if a complaint or non-conforming report is categorized as a P5-mislabeled for the following reasons, then it falls into the Red category and a CAPA must be opened: incorrect human readable information on the primary packaging label, incomplete/illegible information on secondary packaging or no insert included in the secondary packaging…

5. Failure to investigate complaints involving the possible failure of labeling to meet any of its specifications as required by 21 C.F.R. § 820.198(c). Specifically, your firm did not investigate several complaints to determine a root cause for the complaint and/or the determination whether the issues described in the complaint(s) extended to other lot(s) of product…

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected…

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,
Ronald M. Pace
District Director,
New York District”

I have omitted, in the interest of brevity, the detailed examples of each of the cited failures. These can be found in the Warning Letter posted on FDA’s web site. A complete list of eFoodAlert articles about CooperVision contact lens problems can be accessed by clicking on the Toric Recalls tab at the top of the page.