Guardian Drug Company Recalls PediaCare, Other OTC Products

On March 7, 2012, Guardian Drug Company issued the following notice to its customers:

Guardian Drug Company Issues Voluntary Nationwide Recall of 71 lots of Over- the- Counter Simethicone Containing Products Due to possible microbial contamination with Burkholderia cepacia

March 07, 2012: Guardian Drug Company, (Guardian) Dayton, NJ is voluntarily recalling the product lots listed in the link below to the retail level.

Guardian is initiating this voluntary recall because the raw material simethicone emulsion lots, which were used in manufacturing of the product lots listed below, were voluntarily recalled by the supplier for possible microbial contamination with Burkholderia cepacia.

B. cepacia does not usually cause infections in the healthy population, however can cause infections in at risk populations including cystic fibrosis patients, immunocompromised patients, and children and infants with immature immune systems. Guardian has not received any reports of adverse events related to this recall.

Guardian has tested the raw material lots which were recalled later and the finished product lots manufactured with the same recalled raw material. None have shown presence of B. cepacia. However, Guardian is initiating this recall as suggested by the raw material supplier and for precautionary measure.

Guardian is notifying all customers who may have received lots listed in the link below and arranging for the return of products. Distributors and retailers that have product which is being recalled should immediately stop distribution and sales of the listed products.

Customers with questions regarding this recall can contact Guardian by calling 609-860- 2600 extension 109 on Monday to Friday 9.00 am to 4.00 pm or e-mail: recall@guardiandrug.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm1 • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form. • Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Guardian is a manufacturer of Over-The-Counter (OTC) Pharmaceutical products, specializing in store-brand products.

This retail-level recall may have been conducted with the knowledge of FDA, the consuming public was never made aware of the potential bacterial contamination – until today (March 23rd), that is, when Food City posted a notice that several PediaCare OTC products had been recalled.

The Guardian recall affects four different products – Maximum Strength Alumox Cherry Liquid (Product Code 508), Extra Strength Megacid Original Liquid (Product code 516), Non-Staining Infants Gas Relief Drops (Product Code 520) and Infants Gas Relief Drops (Product Code 521) – sold under various different store brand names.

CVS Fast Relief Maximum Strength Antacid, Cherry Flavor

Lot 508-1596; Expiry 06/2012
Lot 508-1810; Expiry 08/2012
Lot 508-1853; Expiry 09/2012
Lot 508-1951; Expiry 09/2012
Lot 508-1992; Expiry 10/2012
Lot 508-2085; Expiry 11/2012
Lot 508-2108; Expiry 11/2012
Lot 508-2236; Expiry 12/2012
Lot 508-2272; Expiry 12/2012
Lot 508-2273; Expiry 12/2012
Lot 508-2319; Expiry 01/2013
Lot 508-2433; Expiry 02/2013
Lot 508-2434; Expiry 02/2013
Lot 508-2477; Expiry 02/2013
Lot 508-2647; Expiry 03/2013
Lot 508-2648; Expiry 03/2013
Lot 508-2649; Expiry 03/2013
Lot 508-2650; Expiry 03/2013
Lot 508-3065; Expiry 05/2013
Lot 508-3066; Expiry 05/2013

Wal-Mart (Equate) Maximum Strength Antacid, Cherry Flavor

Lot 508-2459; Expiry 02/2013
Lot 508-2460; Expiry 02/2013
Lot 508-2461; Expiry 02/2013
Lot 508-2462; Expiry 02/2013
Lot 508-2473; Expiry 02/2013
Lot 508-2474; Expiry 02/2013
Lot 508-2475; Expiry 02/2013
Lot 508-2476; Expiry 02/2013
Lot 508-2818; Expiry 04/2013
Lot 508-2819; Expiry 04/2013
Lot 508-2820; Expiry 04/2013
Lot 508-2835; Expiry 04/2013
Lot 508-2836; Expiry 04/2013
Lot 508-2852; Expiry 04/2013
Lot 508-2853; Expiry 04/2013
Lot 508-2909; Expiry 04/2013
Lot 508-2910; Expiry 05/2013

Discount Drug Mart Extra Strength Antacid, Original Flavor

Lot 516-1999; Expiry 10/2012

Discount Drug Mart Infant’s Gas Relief Liquid Drops, Non-Staining

Lot 520-1641; Expiry 06/2012
Lot 520-2492; Expiry 02/2013

Kmart Corp. (Smart sense) Extra Strength Antacid Antigas, Original Flavor

Lot 516-1999; Expiry 10/2012
Lot 516-2367; Expiry 01/2013
Lot 516-2577; Expiry 02/2013
Lot 516-2846; Expiry 04/2013
Lot 516-3067; Expiry 06/2013
Lot 516-3147; Expiry 06/2013

Kmart Corp. (Smart sense) Infant’s Gas Relief Drops, Non-Staining

Lot 520-1641; Expiry 06/2012
Lot 520-1900; Expiry 09/2012
Lot 520-2492; Expiry 02/2013
Lot 520-2516; Expiry 02/2013

Dollar General (DG health) Infant’s Gas Relief Liquid Drops, Non-Staining

Lot 520-1597; Expiry 06/2012
Lot 520-1641; Expiry 06/2012
Lot 520-1807; Expiry 08/2012
Lot 520-1900; Expiry 09/2012
Lot 520-2056; Expiry 11/2012
Lot 520-2172; Expiry 11/2012
Lot 520-2492; Expiry 02/2013
Lot 520-2516; Expiry 02/2013
Lot 520-2711; Expiry 03/2013
Lot 520-2773; Expiry 04/2013
Lot 520-2958; Expiry 05/2013
Lot 520-3104; Expiry 06/2013
Lot 520-3155; Expiry 06/2013

Blacksmith Brands (PediaCare) Infant’s Gas Relief Drops, Dye Free

Lot 520-1829; Expiry 08/2012
Lot 520-2047; Expiry 10/2012
Lot 520-2488; Expiry 02/2013
Lot 520-2513; Expiry 02/2013
Lot 520-2515; Expiry 02/2013
Lot 520-2660; Expiry 03/2013

Blacksmith Brands (PediaCare) Infant’s Gas Relief, Simethicone – Antigas

Lot 521-1849; Expiry 08/2012
Lot 521-2048; Expiry 10/2012
Lot 521-2512; Expiry 02/2013
Lot 521-2517; Expiry 04/2013

Quality Choice (QC) Infant’s Gas Relief Drops, Non-Staining

Lot 520-1597; Expiry 06/2012
Lot 520-1900; Expiry 09/2012
Lot 520-2056; Expiry 11/2012
Lot 520-2958; Expiry 05/2013

Select Brand Infant’s Gas Relief Drops, Non-Staining

Lot 520-1597; Expiry 06/2012
Lot 520-1900; Expiry 09/2012
Lot 520-2056; Expiry 11/2012
Lot 520-2492; Expiry 02/2013
Lot 520-2516; Expiry 02/2013
Lot 520-2958; Expiry 05/2013

AmerisourceBergen (Good Neighbor Pharmacy) Infant’s Gas Relief Drops, Antigas

Lot 521-1642; Expiry 07/2012
Lot 521-1870; Expiry 09/2012
Lot 521-2057; Expiry 11/2012
Lot 521-2857; Expiry 04/2013
Lot 521-3108; Expiry 06/2013

McKesson (Sun Mark) Gas Relief Drops, Infant’s

Lot 521-1642; Expiry 07/2012
Lot 521-1870; Expiry 09/2012
Lot 521-2057; Expiry 11/2012
Lot 521-2857; Expiry 04/2013
Lot 521-3108; Expiry 06/2013

With the exception of Food City, not a single retailer whose store brand was affected by this recall has posted a consumer-level recall notice. If you have purchased one of these products, please check with your pharmacy, grocery store or “big box” store for instructions.

Or call Guardian Drug Company directly by telephone at 609-860-2600, ext. 109, or by Email (recall@guardiandrug.com).

Where’s The (New Food Classics) Beef?

The following is a consolidation of retail distribution information for the ground beef products manufactured at New Food Classic’s Establishment 761. The recalled products were sold under the brand names listed below, and bear one of the following codes:

Best before date from BB 2012 JA 01 up to and including BB 2013 FE 15;
Production code with a format of 11 JL 01 up to and including 12 FE 15; or
5-digit lot code where the last four digits are 1831 or greater.

List of Affected Brands and Products Sold at Retail (Updated March 26, 2012)

Best Value Beef Burgers
BV Balance Lean Sirloin Beef Burgers
Calgary Stampede Western-style BBQ Sauce Beef Burgers
Country Morning Seasoned Beef Burgers
Country Morning Beef Burgers
Country Morning Gold Mozzarella & Bacon Beef Burger
Country Morning Gold Philly Cheese Burgers with Monterey Jack Cheese, Green Peppers, Onions & Mushrooms
Country Morning Gold Prime Rib Beef Burger with 70% Prime Rib
Country Morning Gold Range Fed Angus Beef Burgers
Country Morning Gold Seasoned Sirloin Beef Burger
Country Morning Gold Sliders – prime Rib Beef Burger with 75% Prime Rib
Country Morning Sliders, Philly Cheese Mini Beef Burgers with Monterey Jack Cheese, Green Peppers, Onions & Mushrooms
Country Morning Gold Traditional Gourmet Beef Burger
Country Morning Gold Traditional Texas-Size Gourmet Beef Burger
Country Morning Gold Western BBQ Burger
Exclusive Selections Angus Beef Burgers
Exclusive Selections Prime Rib Beef Burgers
Grillhouse Angus Beef Slider, Mini Angus Beef Burger
Grillhouse Beef Burger with Montreal STeak Spice
Grillhouse Lean Beef Burger
Grillhouse Our Double Prime Sirloin and Prime Rib
Grillhouse Prime Rib Beef Burger made with 70% Prime Rib and Horseradish
Heritage Angus Beef Range-Fed Angus Beef Burgers
Irresistibles Angus Beef Burgers
Irresisitbles Beef Burgers Mushroom Swiss
Irresistibles Lean Sirloin Beef Burgers, Roasted Garlic and Onion
Irresistibles Sirloin Beef Burgers, Original
Irresistibles Sirloin Beef Burgers, Peppercorn
Irresistibles Life Smart Lean Sirloin Beef Burgers
Keg Prime Rib Beef Burgers made with 70% Prime Rib
Keg Prime Rib Beef Burgers made with 75% Prime Rib
Maple Lodge Farms Halal Beef Burgers
no name 12 Beef Burgers
no name Club Pack Beef Steakettes
Our Finest Philly Cheese Beef Burgers, Monterey Jack, Green Peppers, Onions, Mushrooms
Our Finest Prime Cuts, Sirloin & Prime Rib Beef Burgers made with 60% sirloin and 20% prime rib
Our Finest Traditional Recipe Beef Burger
Overwaitea Prime Rib Beef Burgers made with 70% Prime Rib
PC Bacon Double Cheese Burger
PC Beef Burgers made with Processed Swiss Cheese Food and Portobello Mushrooms
PC GIANTICO Beef Burger
PC Smokin Stampede Beef Burger
PC Thick & Juice Beef Burger
PC Thick & Juicy Burger
PC Thick & Juicy™ Beef Burgers Angus
PC Thick & Juicy™ Prime Rib Beef Burgers made with 75% Prime Rib
PC Thick & Juicy™ Smokin Stampede Beef Burgers
PC Triple Cheese, Thick & Juicy™ Beef Burgers
PC Blue Menu Angus Sliders, Mini Lean Angus Beef Burgers
PC Blue Menu Angus, Thick & Juicy™ Lean Beef Burgers
PC Blue Menu Portion Wise, Extra Lean Thick and Juicy™ Beef Burgers
PC Blue Menu Thick & Juicy™ Lean Beef Burgers
PC Butchers Choice BC Beef Burger Garlic Peppercorn
PC Butchers Choice BC Hickory BBQ Beef Burger
Q Burger Beef Burgers
Q Burger Beef Burgers Uncooked
Simply Food Angus Beef Sliders Mini Beef Burgers
Simply Food Lean Beef Burgers
Simply Food Prime Rib Beef Burger with 50% Prime Rib
Spring Creek Our Gourmet Angus Beef Burgers
Sunspun Bearpaw Shaped Beef Burgers
Webers Beef Burgers
Webers Beef Burgers «Bucket of Burgers (12) »
Western Family “PHILLY CHEESE STEAK” BEEF BURGERS
Western Family Angus Beef Sliders, Mini burgers made with 50% Angus beef
Western Family Cheddar & Bacon Angus Beef Burgers, with real cheddar cheese and bacon
Western Family Homestyle Recipe Beef Burgers with onions and spices like mom used to make
Western Family Serrano and Jalapeno Beef Burgers with Monterey Jack cheese, serrano and jalapeno peppers
Western Family Serrano and Jalapeno Beef Sliders, Mini beef burgers with Monterey Jack cheese, serrano and jalapeno peppers
Zabiha Halal Beef Burgers

Frozen Beef Products Recalled from Sobeys Inc. network of stores, as reported to eFoodAlert by Barbara McCully, Director of Communications for Sobeys Inc.

Atlantic Provinces

Zabiha Halal Beef Burgers:- 6 x 907 g; UPC 067714006728; Item #298501; All Production Codes

Quebec

No recalled products

Ontario

Licks Beef Burger:- 12 x 612 g; UPC 829345 70037; Item #284189; ALL CODES FROM New Food Classics establishment 761. Codes 09-63814 and 03-12014 from Cargill Meat are NOT recalled
Heritage Burgers Angus Beef:- 12 x 852 g; UPC 628896 00112; Item #247469; All Lot Codes
Heritage Burger Lean Angus:- 6 x 568 g; UPC 62889 600208; Item #287387; All Lot Codes

Western Canada

Calgary Stampede Beef Burgers:- 12 x 1.02 kg; UPC 6666953214; Item #505055; All codes with EST#761 on the package.
Carmen Creek Bison Burgers:- 12 x 568 g; UPC 6666964117; Item #547589; All codes with EST#761 on the package.
Calgary Stampede Beef Burgers:- 12 x 725 g; UPC 6666953213; Item #115030; All codes with EST#761 on the package.
Keg Prime Rib Burger:- 12 x 1.02 kg; UPC 69567600600; Item #299575; All codes with Establishment #761 on the package.
Keg Prime Rib Slider:- 12 x 852 g; UPC 69567600610; Item #299577; All codes with Establishment #761 on the package.
Q Brand Burgers:- 8 x 2.27 kg; UPC 6666953343; Item #283073; All codes with Establishment #761 on the package.
Burger Bites Cooked Beef Burgers with Buns:- 12 x 936 g; UPC 6666951857; Item #229672; All codes with Establishment #761 on the package.
Heritage Burgers Angus Beef:- 12 x 852 g; UPC 62889600112; Item #247469; All codes with Establishment #761 on the package.
Grillhouse Burger Angus Beef:- 12 x 684 g; UPC 6666955400; Item #281308; All codes with Establishment #761 on the package.
Spring Creek Burgers Angus Beef Gourmet:- 6 x 907 g; UPC 68831500301; Item #258268; All codes with Establishment #761 on the package.
Grillhouse Burger Angus Beef:- 12 x 540 g; UPC 6666951921; Item #281729; All codes with Establishment #761 on the package.
Grillhouse Burger Angus Beef:- 12 x 6Pk, 113 g; UPC 6666951868; Item #256824; All codes with Establishment #761 on the package.
Q Brand Burgers:- 10 x 2.27 kg; UPC 6666953370; Item #505264; All codes with Establishment #761 on the package.

Thrifty Foods

Carmen Creek Gourmet Bison:- Net 907g/ 2lbs 6 burgers; UPC 875485000056; EST 761 all codes
Calgary Stampede Burgers:- Net 1.02 kg, 6 beef burgers; UPC 066669532146; EST #761 all codes

None of Sobeys’ private label products are impacted by the CFIA Health Hazard Alert.

Saskatoon Co-op

Country Morning® and Country Morning® Gold are brands that are exclusive to Saskatoon Co-op, according to the Co-op’s web site.

The North West Company has removed all ground beef products manufactured at Establishment 761 from all Giant Tiger West, Northern, and NorthMart stores. The affected stores and locations include:

Giant Tiger:- British Columbia, Alberta, Saskatchewan, Manitoba
Northern:- British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Newfoundland and Labrador, Northwest Territories, Yukon and Nunavut
NorthMart:- Saskatchewan, Manitoba, Nunavut, Northwest Territories, Newfoundland and Labrador

Other Supermarkets and Grocery Stores

Buy-Low Foods Ltd (Western Family brand): Alberta and British Columbia
Cash&Carry/RCWC Ontario Corporation (no name Club Pack Beef Steakettes):- Ontario
COOP (Country Morning Beef Burgers):-British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, North West Territories, Yukon Territories and Nunavut
Extra Foods (no name Club Pack Beef Steakettes):- Ontario, British Columbia, Alberta, Saskatchewan and Manitoba
Extra Foods no frills (no name Club Pack Beef Steakettes):- British Columbia, Alberta, Saskatchewan and Manitoba
Freshmart (no name Club Pack Beef Steakettes):- Ontario
Giant Tiger (Best Value Beef Burgers):- Distributed to stores in British Columbia, Alberta, Saskatchewan and Manitoba. Giant Tiger has removed all Best Value Beef Burger products from its stores nationwide.
Loblaws (no name Club Pack Beef Steakettes and no name 12 Beef Burgers):- North West Territories, Yukon Territories and Nunavut
Loblaws Great Food (no name Club Pack Beef Steakettes):- Ontario
no frills (no name Club Pack Beef Steakettes):- Ontario
Metro-Richelieu (Irresistibles brand):- Includes metro, Metro Plus, Super C, Les 5 Saisons, food Basics, Marché Richelieu, marché ami, and Marché Extra! supermarkets and grocery stores.
Northern Canada (Best Value Beef Burgers):- British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Newfoundland and Labrador, Northwest Territories and Nunavut.
Overwaitea Foods (Western Family brand):- British Columbia
RCWC West Corporate (no name Club Pack Beef Steakettes):- Ontario
Real Canadian Superstore (no name Club Pack Beef Steakettes):- Ontario
Real Canadian Superstore West Corporate (no name Club Pack Beef Steakettes):- British Columbia, Alberta, Saskatchewan and Manitoba
Shop Easy/SuperValue (no name Club Pack Beef Steakettes):- British Columbia, Alberta, Saskatchewan and Manitoba
Superstore (no name Club Pack Beef Steakettes):- British Columbia, Alberta, Saskatchewan and Manitoba
TGP (Country Morning Beef Burgers):-British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, North West Territories, Yukon Territories and Nunavut
Value-mart (no name Club Pack Beef Steakettes):- Ontario
Your Independent Grocer (no name Club Pack Beef Steakettes):- Ontario, British Columbia, Alberta, Saskatchewan and Manitoba
Zehrs (no name Club Pack Beef Steakettes):- Ontario
Zehrs Great Food (no name Club Pack Beef Steakettes):- Ontario

NOTE: This is not a comprehensive list of retailers. It will be updated as more information becomes available. If you learn of a retailer that carried one or more of the recalled products, please post a comment or email me directly with the information.

Stealth Recalls, European Style

I’ve been complaining recently about Stealth Recalls in the USA – those unpublicized recalls undertaken with FDA knowledge, but without informing consumers.

My complaints notwithstanding, I’m the first to admit that most recalls in the USA are publicized by press release and appear on the FDA or USDA recall web page. Often, they are reposted on various State web sites. In fact, recalls and food safety alerts are far better publicized overall in the USA than in Europe.

Several European governments offer fairly detailed food safety recall and alert information over the Internet – the United Kingdom, the Republic of Ireland, Belgium and Denmark are a few of the best examples. Recently – in the aftermath of last summer’s deadly E. coli O104:H4 outbreak – Germany has begun posting detailed food safety recall information.

The performance of Italy – where the art of cuisine was born – is less than stellar, as witness last year’s botulism episode involving Bio Gaudiano’s Olives Stuffed with Almonds. A jar of this company’s olives was responsible for two cases of botulism in Finland. One of the victims – an elderly woman – died; a second victim from the same household survived.

The manufacturer withdrew all production lots of Almond-stuffed olives from the market last October and expanded the product withdrawn in December 2011 to encompass the entire outstanding stock. While Italian consumers were advised of the initial product recall, their Ministry of Health did not bother informing the population of the expanded recall. Italians had to rely on the Irish and Finnish governments for information on the expanded list of recalled products.

France – the birthplace of Appert, Pasteur, and the science of food preservation – is even worse. Even though the Bio Gaudiano Almond-stuffed Olives were distributed to France, the French government site never notified the public of this botulism-related recall.

France is shockingly lax in its food safety consumer alerts. Last December, I reported on the Salmonella outbreak linked to Label Rouge dried sausage products (manufactured by La Société Salaison Polette ZA). The official recall notice referenced a “strong suspicion” that Salmonella was present in the products. The notification issued to member countries of the European Union (RASFF Notification #2011.1880) referred to a foodborne Salmonella outbreak.

Nor has France turned over a new leaf in the New Year. In February, the French government notified European Union members (RASFF Notification #2012.0265) that a French-manufactured chilled ready-to-eat sausage spread was contaminated with Salmonella. The spread was distributed both in France and in Germany. There was no public notification of the product recall either in France or in Germany, and the manufacturer and brand never were identified.

I have yet to encounter a reasonable justification for withholding this food safety information from the consuming public.

I challenge the Rapid Alert System for Food and Feed to reveal brand names and manufacturers of recalled and withdrawn products – especially ready-to-eat products, and foods that are contaminated with pathogenic microbes.

I challenge France and Italy to match their EU partners – the UK, Denmark, Germany, and even Greece – in alerting the public to food safety recalls and alerts.

And I challenge the US government to take the world lead in improving the dissemination of food safety alerts and recall information.