Recalls and Alerts: January 30, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

  • Allergy Alert: Walgreen Co. recalls Walgreens Chocolate-Covered Raisins (13-oz; Best by date of Oct 42012A1; UPC 04902245661), because the packages may contain Walgreens Bridge Mix, and thus may contain undeclared peanut, almond and soy ingredients. The recalled product, which was manufactured for Walgreen Co. by GKI Foods, Inc. (Brighton, MI), was distributed through Walgreen Co. idstribution centers in Arizona, Connecticut and California, and to Walgreens retail stores in the Northeastern and Western USA.
  • Food Safety Recall Update: USDA releases retail distribution list for Julienne Salad Products that were recalled by 18th Street Deli Inc. due to possible contamination with Listeria monocytogenes.
  • Personal Care Product Safety Recall: Johnson & Johnson Consumer Companies, Inc. recalls AVEENO® Baby Calming Comfort® Lotion (UPC 38137-0036456; Lot #0161LK), after FDA lab tests found that the lot exceeded specifications for “common bacteria.” The company has recalled the product from retailers in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall.
  • Animal Health Product Safety Alert: Novartis Animal Health has warned veterinarians that foreign tablets may be found in certain bottles of Clomicalm (climipramine hydrochloride) tablets. The company has issued a “Dear Doctor” letter.

Canada

  • Allergy Alert: Kraft Canada Inc. recalls Kraft Dinner Smart Vegetables 3 Cheese (150g; Code 12AL11 M2) and Kraft Dinner Smart Vegetables (150g; Codes 12AL11 M2 and 12AL12 M2), due to the presence of undeclared tartrazine.
  • Food Safety Recall: Drogheria Fine Épicerie (Montreal, QC) recalls Ragu Di Carne de Veau/Veal Stew (1-litre glass jars; All jars sold up to and including January 26, 2012), because the manner of preparation was not adequate to ensure microbiological safety.

Europe

Asia, Africa and the Pacific Islands

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

FDA Inspection Report Slams Novartis Inaction

“As of 12/12/11, your firm is overdue (untimely) with adequately conducting approximately 1,360 investigations you have received from consumer complaints (1332 are major, 31 are critical). This backlog of overdue complaints has been over 1,000 in number since at least 8/30/11.”

FDA to Novartis Consumer Health (Lincoln, Nebraska), January 20, 2012

FDA has just released (January 30, 2012) a scathing 23-page Inspectional Observations (Form 483) report, which the agency issued to Novartis Consumer Health ten days ago, following completion of a reinspection of the company’s Lincoln, Nebraska facility.

The inspection report details numerous examples of egregious and unconscionable disregard for consumer safety on the part of Novartis Consumer Health – many of them issues that remain unaddressed since the facility was inspected last July. Consumer complaints of product mix-ups and chipped tablets have either not been investigated, or the investigation was inadequate, incomplete or delayed.

Some of the most flagrant deficiencies highlighted in the latest FDA report include:

  • As of 12/21/11, your firm … has approximately 360 consumer returned complaint samples of various products (major and critical complaints) that have not been thoroughly reviewed by your Quality Unit. … [The problems] requiring investigation include, but are not limited to: foreign product, foreign object, suspected tampering, chipped/cracked/crumbled tablets, broken/missing seal, etc. … Your firm is outside of procedural timeframes for completing approximately 340 open Corrective and Preventative Action requirements … and 48 deviation … investigations.
  • [I]nvestigation fails to address how “28 assorted tablets” (some not packaged in the room, such as Gas X, Soft Gels, etc) could have entered a room dedicated to packaging other products.
  • [I]nvestigation, opened 11/18/11 and closed 12/16/11, into a complaint for “12 extra tablets”, found by a pharmacist after opening a sealed bottle of Morphine Sulfate ER 30mg… is deficient. … This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints.
  • Your most recent consumer complaint (opened 12/16/12 and closed 12/20/11) into Bufferin RS Tablets, Lot: 10095189, for partial/incomplete tablet caplets, dues not address all lots of product potentially affected by the problem of over-compressed tablets identified as the root cause. Your firm was aware of Partial/Incomplete Bufferin tablets/caplets issues since at least 2009, yet a Medical safety Assessment Report was not released until 10/14/11. There is no justification or explanation for the approximate 2 year delay in obtaining this report.
  • There is not root cause identified for the foreign tablets potentially in a Prevacid 15 MG Capsule container. … You have had 35 mixed tablet/foreign products for Prevacid 15 mg Capsules since 2009.
  • It is important to understand because of your firm’s failure to adequately and thoroughly conduct investigations, it is difficult to determine how widespread the problems are at your firm…
  • Your packaging line clearance operators failed to adequately clean packaging lines (and areas around packaging lines) during your “major” cleaning efforts of this equipment…
  • Your most recent Annual Product Review (APR) for Bufferin Extra Strength Tablets and Bufferin Regular Strength Tablets (2010) is incorrect. …
  • Your most recent 2011 Annual Product Review for Excedrin Extra Strength Express Gels … approved 5/27/11, is deficient. The report fails to document the consistent trend of complaints received by your firm for “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” regarding this product. … Your firm has been aware of “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” for this product (Express Gels) since at least 2009, yet a complete market correction (due to this problem) was not executed until 1/8/12, which occurred during the course of this FDA inspection.
  • The conclusion in your most recently completed 2011 Annual Product Review for Benefiber Plus Calcium Powder, signed as acceptable on 6/27/11, is not supported by the information in the report.
  • You have failed to document the root cause, and implement effective corrective and preventative actions, regarding product mix-up complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009. (Referring to products such as: Excedrin family products, Prevacid, narcotic products, etc… Your foreign product recall assessment, dated 10/17/11, states you have received approximately 70 confirmed, returned customer complaint, mix-up samples containing only NCH-Lincoln produced product. In total, There have been 400 complaint cases of this type since 2009.
  • There is an inadequate number of Quality Unit personnel in your firm to conduct timely, correct and thorough reviews of the products you manufacture.

And, repeated over and over again throughout the 23-page report, is the statement – highlighted BY THE FDA INSPECTOR in upper case and bold-face:

THIS IS A REPEAT VIOLATION FROM THE PREVIOUS INSPECTION AT YOUR FIRM DATED 6/13-7/8/11

I would not be surprised to see another recall announcement from Novartis Consumer Health – one that covers all products manufactured by the company since 2009 at its Lincoln, Nebraska production plant.

Excedrin Recall Spills Into Canada

Novartis Consumer Health Canada Inc. has recalled two Excedrin products, according to a report released on January 13, 2012 by Health Canada.

The Canadian recall is part of a much larger recall of Excedrin, Bufferin, NoDoz and Gas-X Prevention products announced a week ago by Novartis Consumer Health in the USA. The Lincoln, Nebraska manufacturing plant where these products were made was the subject of a scathing inspection report issued by FDA in July 2011, and has been closed temporarily to allow for maintenance and improvements.

The Canadian recall encompasses all production lots of Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets (Expiration dates on or before December 20, 2014).

The recalled products were sold in Canada by Costco Canada and may also have been carried by other retail grocers, supermarkets and pharmacies.

For more information on the Novartis recalls, please select the Excedrin, Etc. Recalls tab.