Tags

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).

Advertisements