Tag: Health

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).

Recalls and Alerts: March 23, 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.

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: Whole Foods Market (Austin, TX) recalls Mini Chocolate Chip Cookies (UPC 2-21485-20399-5; Sell-by dates of March 8, 2012 through March 28, 2012), because the product contains undeclared walnuts. The recalled cookies were sold at Whole Foods Market stores in Arkansas, Louisiana, Oklahoma and Texas.
  • Food Safety Recall Update: USDA releases retail distribution list for ready-to-eat beef sausage products recalled by Southside Market & BBQ due to contamination with Listeria monocytogenes.
  • Food Safety Recall/Quarantine Order: The California Department of Food and Agriculture has announced a statewide recall and quarantine order for raw milk products from Claravale Farm (San Benito County, CA), after the agency confirmed the detection of Campylobacter in raw cream from the farm. While no illnesses have been definitively linked to the Claravale Farm products, an epidemiological investigation into clusters of Campylobacter illness is in progress.
  • Public Health Alert (Ohio): The Ohio Department of Agriculture issues a public health alert for various meat and poultry products produced by Olde Strasburg Meats that were misbranded and produced without the benefit of inspection. The list of products includes: Pulled BBQ pork, Pulled BBQ beef, Pulled BBQ chicken, Beef jerky, Chip chop ham, and Ground beef (1-lb chubs sold through Valley FArm Meats retail store). The products are believed to have been produced and shipped between August 2011 and February 9, 2012.
  • OTC Pharmaceutical Product Safety Recall: Guardian Drug Company (Dayton, NJ) recalls Infants Gas Relief Drops, including PediaCare, Sun Mark and Good Neighbor Pharmacy brands (Lot Nos. 521-1849, 521-2048, 521-2512, 521-2517, 521-1642, 521-1870, 521-2057, 521-2857, and 521-3108), Maximum Strength Alumox Cherry Liquid (Product code 508), Extra Strength Megacid Original Liquid (Product code 516) and Non-staining Infant’s Gas Relief Drops (Product code 520), because the raw material simethicone emulsion lots that were used in the manufacture of these products were recalled by the supplier for possible contamination with Burkholderia cepacia.
  • OTC Pharmaceutical Product Safety Recall: Food City advises its customers that the following PediaCare items have been recalled by the manufacturer (Guardian Drug Company, see above): Pediacare Infant Drops Cherry, 1 oz; Pediacare Concentrated Fever Reducing Infant Cherry, 0.5 oz; Pediacare Infant Drops Grape, 1 oz; and Pediacare Concentrated Fever Reducing Infant Grape, 0.5 oz.

Europe

  • Food Safety Recall and Allergy Alert (Finland): Kookosravinto ME Ay recalls VitaHamppu Bread Flour (Best before 06/30/2012) and VitaMantell Flour (Best before 15/05/2012), due to Salmonella contamination (VitaHamppu Bread Flour) and the presence of undeclared soy (both products).
  • Food Safety Recall (Ireland): Rockabill Shellfish Ltd. recalls Frozen Swordfish Steaks (Product of Portugal; Sold loose between 03.11.2011 and 17.12.2011), due to elevated levels of mercury contamination. The recalled product was supplied to Taste of the Sea, Glasnevin, Dublin 9.
  • Food Safety Notification (EU #2012.0440): Incorrect labeling on chilled honey and mustard ham from the United Kingdom; distributed to Gibraltar and the United Kingdom.
  • Food Safety Notification (EU #2012.0441): Histamine in canned frozen tuna in oil from Spain; distributed to Italy.

Australia and New Zealand

  • Allergy Alert: Woolworths Ltd. recalls Duncan Hines Moist Deluxe Devil’s Food Cupcakes Mix and Duncan Hines Moist Deluxe Confetti Cupcakes Mix (255g red cardboard box; All best before dates; Product of USA), due to the presence of undeclared milk and traces of tree nuts. The recalled mixes were sold in Woolworths/Safeway/Food For Less/Flemings Supermarkets nationally.

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: March 22, 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.

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

  • Food Safety Recall: Southside Market & BBQ (Elgin, TX) recalls Southside Market & BBQ Original Beef Sausage (16 oz pkgs; Lot #065-E), Southside Market & BBQ Original Beef Sausage (16 and 48 oz pkgs; Lot #065-A, 065-B, o65-C and 065-D), and Southside Market & BBQ 1882 Hot Recipe Beef Sausage (16 oz pkgs; Lot #065-D), because the ready-to-eat beef sausages may be contaminated with Listeria monocytogenes. The recalled sausages were produced on March 5, 2012 and distributed to retail warehouses in Texas, as well as through internet sales to California, Florida, Illinois, Louisiana and Texas. H-E-B, a Texas supermarket chain, has advised its customers of this recall.

Canada

  • Allergy Alert: Quality Natural Foods Canada Inc. recalls Haldiram’s Indian Snacks All-in-One (160g pkgs; UPC 8 904004 402025), due to the presence of undeclared sesame seeds. The recalled snacks were sold in retail stores across Canada.
  • Allergy Alert: Boucherie Jean-Guy (Granby, QC) recalls Tortière, Ragout, Pâté au saumon and Pâté mexicain, due to the presence of undeclared milk, wheat, soy and/or sulfites.
  • Allergy Alert: Elderflower Organic Farm recalls Elderflower Organic Farm Sprouted Lentil Burgers (various count pkgs; All lots where tahini is declared in the ingredient list), due to the presence of undeclared sesame seeds. The recalled product was distributed in Prince Edward Island to retailers and to the hotel/restaurant/institutional trade.
  • Allergy Alert: Santa Maria Foods ULC recalls Divella Gnocchi 45 pasta (500g; UPC 8 005121 000450; Code 17 FR E2 A; Best before 31/12/2013), due to the presence of undeclared egg. The recalled product was sold in retail stores in Nova Scotia and Quebec.
  • Food Safety Recall: L’Arôme des Bois (Rawdon, QC) recalls Têtes de violon marinées/Marinated Fiddleheads (190ml glass jars; no expiry dates indicated), because the product was prepared in a microbiologically safe manner and was displayed for sale without refrigeration.
  • Pharmaceutical Product Safety Recall: Sandoz Canada Inc. recalls Morphine Sulfate Injection, 2 mg/mL (Lot CC29824; Exp. 2014-12), after a Toronto hospital found one box labelled as morphine ampoules that actually contained ampoules of isoproterenol. Sandoz Canada is inspecting its remaining inventory of morphine packages from affected lot to confirm that all of the packages contain the correct product.

Europe

Australia and New Zealand

  • Food Safety Recall (Australia): Goodman Fielder recalls Meadow Lea Extra Light Margarine (500g yellow plastic tub; Best before 28 AUG 2012), due to possible contamination with a cleaning solution. The recalled product was distributed through Coles Supermarkets, independent supermarkets and corner stores across Australia.
  • Food Recall (New Zealand): Homecare Health Management Ltd. recalls Lotcare Gold Grow Up Nutritional Supplement (808g can; Batch number PCT11287P; Use by 20/10/2013 and 21/10/2013), because the product does not fully meet the New Zealand requirements for composition.

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.