Author: Phyllis Entis

Recalls and Alerts: December 22, 2011

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.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: Market Basket recalls Market Basket Solid White Albacore Tuna in Water (5oz; Best buy dates of August 18, 2014 and August 19, 2014), due to the presence of undeclared soy. The product was sold only at Market Basket stores in Massachusetts and New Hampshire.
  • Food Safety Recall: Starwest Botanicals (Rancho Cordova, CA) recalls Starwest Organic Whole Celery Seed (2-oz, Lot #F7073; 1-lb, Lot #40203), because the product may be contaminated with Salmonella. The recalled product was sold between April 26, 2011 and December 14, 2011.
  • Food Safety Recall: Cal Fresco, LLC recalls fresh Jalapeño (Lot #205610) and Serrano (Lot #205467) chili peppers that may be contaminated with Salmonella. The Jalapeño peppers were shipped in cases under the Cal Fresco and Grower Alliance labels to retail stores within California, Oregon, Washington, Texas and Canada between December 3 and December 5, 2011. The Serrano peppers were shipped to retailers in Canada (Edmonton, Winnipeg and Vancouver), Southern California, Alaska, Washington and Texas (Dallas). Both products originated in Mexico.
  • Dietary Supplement Safety Recall: Eclectic Institute (Sandy, OR) recalls various freeze-dried capsules containing Gotu Kola and Bladderwrack, because of potential Salmonella contamination. Please refer to the recall notice for complete details of affected products, including lot numbers and dates of sale.
  • FDA Warning Letter: FDA warns The Cake Box, Inc. (Lafayette, CA) that a September 2011 inspection of the company’s bakery documented serious violations of the Current Good Manufacturing Practice regulation for foods. Violations included lack of effective pest control and insanitary conditions.
  • FDA Warning Letter: FDA warns Global Sweet Polyols, LLC (Rehoboth, MA) that a May/June 2011 inspection of the company’s dietary supplement facility revealed failure to comply with the requirements of the Current Good Manufacturing Practice regulations for dietary supplements.
  • FDA Warning Letter: FDA warns Golden Temple of Oregon, LLC (Portland, OR) that a May 2011 inspection of the company’s facility revealed significant violations of the Current Good Manufacturing Practice regulations for dietary supplements.
  • Outbreak Alert/Product “Pull”: Walmart has pulled a single production batch of  Enfamil Newborn infant formula (a Mead Johnson Nutrition brand) from its stores nationwide after the death of a Lebanon, Missouri infant, according to media reports. The infant died from Cronobacter sakazakii (previously known as Enterobacter sakazakii), a rare and often fatal bacterium that occasionally contaminates powdered infant formula.
  • OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
  • Consumer Product Safety Recall: Target Corporation (Minneapolis, MN) recalls Circo Childrens’ 17″ Travel Cases (Cate codes 01/11 through 08/11) because the surface coating on the travel cases contains excessive levels of lead.

Canada

  • Allergy Alert: Uruthira Brothers Ltd. recalls MD brand Lime Cordial (750mL), Passion Fruit Cordial (750mL), Mango Cordial (750mL), Garlic Paste (250g), and Ginger Paste (225g and 350g), due to the presence of undeclared sulphites. The recalled products were distributed to retailers in Alberta, British Columbia, Ontario and Quebec.
  • Food Safety Recall: Maple Crisp Orchards Maple Products recalls Maple Crisp Orchards 100% Pure Pasteurized Apple Cider (2L and 4L; Processed Nov 3/11), due to the presence of patulin, a toxin produced during the growth of certain molds.
  • Food Safety Recall Update: Canada Safeway Ltd. (Calgary, AB) recalls Fresh Serrano Peppers (Product of Mexico, imported from the USA; unlabeled from bulk; sold between December 5 and 20, 2011 inclusive), because the product may be contaminated with Salmonella. The recalled Serrano peppers were sold from bulk at Safeway stores and various independent grocery stores in Alberta, British Columbia, Manitoba, Northwest Territories, Ontario, Saskatchewan and Yukon.
  • Consumer Product Safety Recall: Distributions (Daniel Coderre), Inc., Arden Holdings Inc., Groupe Dynamite Inc., John Bead Corporation Ltd., Bizou International, Frabels Inc., and DeeJay Jewellery Inc. recall various childrens’ trinkets (including necklaces and charms), due to excessive levels of lead and/or cadmium. Please navigate to the individual recall notices for details on the recalled items.

Europe

Asia, Africa and the Pacific Islands

  • Consumer Product Safety Alert (Philippines): Several types of beverage and food containers sold in the market in Metro Manila have been found to contain high levels of antimony, arsenic, cadmium, chromium and lead, according to a survey carried out by the EcoWaste Coalition.
  • Outbreak Alert (Hong Kong): The Centre for Health Protection is investigating a suspected food poisoning outbreak involving 21 people following a workplace Christmas party. The 3 males and 18 females developed abdominal pain, diarrhea and vomiting approximately 9 to 49 hours after sharing a lunch on December 17. One person required hospitalization.
  • OTC Pharmaceutical Product Recall (Fiji): McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
  • Pharmaceutical Product Safety Recall (Hong Kong): B. Braun Medical (H.K.) Limited recalls three Nutriflex Lipid products manufactured in Germany by B. Braun Melsungen AG, because stability testing on the above products had identified potential particulate formation over time.
  • Dietary Supplement Safety Alert (Hong Kong): The Department of Health urges the public not to purchase or use a slimming product identified as 之素囊, as the product may contain the banned ingredients sibutramine, phenolphthalein, fenfluramine and animal thyroid tissue. The product was purchased on the Mainland.
  • Dietary Supplement Safety Alert (Hong Kong): The Department of Health urges the public not to purchase or use Jin Yu Tang Tai Han Kang Pai Pu Ling Jiao Nang, because it was found to contain the undeclared western drugs metformin, rosiglitazone, glibenclamide and phenolphthalein.
  • Outbreak Alert (Hong Kong): The Centre of Health Protection is investigating a confirmed case of listeriosis involving a 32-year old pregnant woman. The baby passed away one day after birth. The woman is in stable condition.

Australia and New Zealand

  • Allergy Alert (Australia): Anchor Foods Pty Ltd. recalls Spencers Cocoa Powder (500g cellophane sachet; all best before dates between 1 JUL 2013 to 5 OCT 2013), IGA Signature Chocolate Cake Mix (500g cardboard packet; Best before 22 NOV 2012 and 12 DEC 2012), IGA Signature Fudge Brownie Mix (500g cardboard packet; Best before 21 AUG 2012 and 21 NOV 2012) and IGA Signature Chocolate Baby Cake Mix (300g cardboard packet; Best before 29 NOV 2012 and 15 Dec 2012), due to the presence of undeclared sesame. The recalled products were manufactured in Australia, using cocoa imported from China.
  • Diet Pill Safety Alert (Australia): The Therapeutic Goods Administration warns consumers that Lipro Diet Pills, which are labeled as 100% herbal, contain the undeclared prescription substance sibutramine. Taking Lipro Diet Pills for weight loss posses a serious health risk. Commercial supply of this product is illegal in Australia; however, it is available through the Internet.

Latin America and the Caribbean

  • Food Safety Notification (EU #2011.1883): Salmonella in ground cumin from the United Kingdom, with raw material from Syria; distributed to Gibraltar, Netherlands Antilles, Poland, Sweden and the United Kingdom. The ground cumin is sold under the Natco Foods brand (100g jar, 100g pack, 400g pack, 1kg pack and 5kg pack), and carries Best before dates of September 2013 and October 2013.
  • OTC Pharmaceutical Product Recall (several Caribbean countries): McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
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.

Recalls and Alerts: December 21, 2011

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.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: Popcorn Palace (Schiller Park, IL) alerts consumers that the following 1-Gallon Value Bags of popcorn contain one or more undeclared allergens: Cheddar Cheese (milk and soy), White Cheddar (milk and soy), Chicago Style (milk and soy), Gourmet Caramel (milk and soy), Rainbow (soy), Caramel Nut (milk, soy, peanuts, almonds and cashews), Chocolate Drizzle Caramel (milk and soy), Macadamia Butter Crunch (milk, soy and macadamia nuts), Cookies & Cream (milk, soy and wheat), and Spicy Cheese (milk, soy and wheat). Affected products were available for purchase after October 1st, 2011 through one of the company’s fundraising programs.
  • Allergy Alert: Price Chopper recalls Price Chopper Raspberry Cheesecake, Blueberry Cheesecake, and Strawberry Cheesecake (24-oz size; Purchased Nov. 29 – Dec 20, 2011), due to the presence of undeclared egg.
  • Food Safety Recall Update: USDA posts retail distribution list for Chuck Fine Ground Beef 80/20 (10-lb chubs) recalled by Tyson Fresh Meats Inc. due to E. coli O157:H7 contamination.
  • Consumer Product Safety Recall: The Zeroll Company (Fort Pierce, FL) recalls Pampered Chef Ice Cream Dippers, because the cap and seal at the end of the scoop handle can fly off with substantial force when the liquid-filled scoop is exposed to warm water.

Canada

  • Allergy Alert: Choy Foong International Trading Co. Ltd. recalls Slow Taste Spice Tofu In Skewers (90g; Lot code 20110611; Best before 30/12/2012), due to the presence of undeclared sesame seeds.
  • Allergy Alert: Choy Foong International Trading Co. Ltd. recalls Thai Top Choice Instant Beef Flavor Paste (225g; All codes), due to the presence of undeclared wheat.
  • Allergy Alert: Marché Marie-Lyne (Longueuil, QC) recalls Danoise à la canelle / Cinnamon Danish (all lots), due to the presence of undeclared eggs.
  • Allergy Alert: Nishimoto Trading Co. Ltd. recalls various dried mushrooms, due to the presence of undeclared sulphites. Please refer to the CFIA recall details for a list of affected products.
  • Food Recall: Salaison Levesque Inc. recalls Levesque Tradition Natural Smoked Ham (1kg; Codes 11JA17 or 12JA17) due to a labeling issue. The product was distributed to retail customers and institutional clients in Alberta, Manitoba, Nunavut, Ontario, Quebec and Saskatchewan.
  • Food Safety Recall/Alert: Importers of fresh jalapeno peppers are recalling the following products (imported from the USA), due to potential Salmonella contamination. The affected products include:
    • Unlabeled from bulk at Safeway stores and various independent grocery stores in Alberta, British Columbia, Manitoba, Northwest Territories, Ontario, Saskatchewan and Yukon, between December 3 and 20, 2011, inclusively.
    • Unlabeled from bulk or in 4.5 kg Cal Fresco brand cases at Loblaws banners (Extra Foods, No Frills, Real Canadian Wholesale Club, Shop Easy, SuperValu, Real Canadian Superstore, Lucky Dollar and Your Independent Grocer) in Alberta, British Columbia, Manitoba and Saskatchewan, between December 3 and 20, 2011, inclusively.

Europe

  • Allergy Alert  (Finland): Meira Nova Oy recalls Catz mixed dried fruits (12.5Kg box; Expiry 27/07/2012; Packed in the Netherlands), due to the presence of sulphites above the allowable limit.
  • Allergy Alert (Sweden): OLW expands its earlier recall of Dill & Chives Chips to include best before dates between 2012-03-27 and 2012-05-23 (40g, 200g, 300g & 450g bags), due to the presence of undeclared traces of milk.
  • Allergy Alert (UK): Asda recalls Asda Frozen Chicken Biryani Steamer (400g; Best before 25 October 2012), due to the presence of undeclared prawns.
  • Food Safety Recall (Denmark): Jin Lan recalls Homemade Tofu (650g plastic tubs; Best before 23-12-2011), due to the presence of the unapproved ingredient, calcium sulphate (gypsum).
  • Food Safety Recall (UK): Natco recalls Natco Ground Cumin (100g jar, 100g pack, 400g pack, 1kg pack and 5kg pack; Best before September 2013 and October 2013), because some of the product is contaminated with Salmonella.

Australia and New Zealand

  • Food Safety Recall (Australia): EKO Australia Pty Ltd. recalls Kamfen Buckwheat Noodles (340g; Best before 2013.04.15), Kamfen Beijing Noodles – Abalone Chicken Soup Flavour (160g; Best before 2013.01.15), and Kamfen Sichuan Noodles – Abalone Chicken Soup Noodles (154g; Best before 2013.01.15), because the products are contaminated with Bacillus cereus. The recalled noodles were imported from Hong Kong and distributed through Asian grocery stores in Sydney, NSW.

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 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.