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Showing posts with label mislabel. Show all posts
Showing posts with label mislabel. Show all posts

Monday, December 13, 2010

Reese Pharmaceutical Company Announces the Voluntary Nationwide Recall of Certain Over-The-Counter Cold Relief Products that are Mislabeled

Reese Pharmaceutical Company of Cleveland, Ohio has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names, listed in the table below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.

Product NameNDC#Lot#
Refenesen Expectorant (guaifenesin 200 mg tablets)10956-752-60;091612 05/11 SS/SCT36 06/26/09
Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)15127-129-60091612 05/11 SS/SCT36 06/26/09
QC Medifin Expectorant (guaifenesin 200 mg)63868-754-60091612 05/11 SS/SCT36 06/26/09
Leader Cough Tabs Expectorant (guaifenesin 200 mg)37205-466-72091612 05/11 SS/SCT36 06/26/09

The mislabeled product does not warn consumers that Acetaminophen may cause liver damage. Ingesting high doses of Acetaminophen can potentially cause severe liver damage. The likelihood of acute liver damage is higher among consumers with pre-existing liver disease and those who drink three or more alcoholic drinks per day. Overdose may specially occur if consumers are also taking other cold/cough products that contain Acetaminophen in addition to the mislabeled product. Contraindications for Phenylephrine are high-blood pressure, poor blood flow to the extremities, and patients on antidepressants known as MAO Inhibitors. Furthermore, products that contain Phenylephrine should be used with caution in patients with high blood pressure, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or enlarged prostate. Consumers who are allergic to any of the ingredients or who have narrow angle glaucoma, or are pregnant or nursing mothers, also should not take the product. However, to date, there have been no reports of adverse events from its use.

This product was distributed nationwide. Consumers who have purchased the product ( lot # 091612 only) should contact Russ or Neal Slaby at 1.800.321.7178 between 7:30-4:00pm eastern standard time for return instructions, medical information, questions, complaints or assistance.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Notification of the recall has been sent to all customers who purchased this product directly from Reese Pharmaceutical Company.

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.

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Monday, April 19, 2010

StarKist Co. Initiates Limited Regional Voluntary Recall of Two SeaSations® Products Due to Undeclared Allergen

As a precautionary measure, due to mislabeling, StarKist Co. is initiating a voluntary recall of two SeaSations® frozen white whole fish fillet products – Thai with Basil, UPC # 80000 50007 and Teriyaki Orange and Ginger, UPC # 80000 50112. All 11.4 oz packages of these two varieties have been recalled, regardless of Best By Date or Manufacturing Code. SeaSations is a test market product, and is therefore in limited retail distribution in the following states: Alabama, California, Florida, Georgia, Indiana, Kentucky, Louisiana, Michigan, Mississippi, South Carolina, Tennessee, and Virginia.

All other varieties of SeaSations are correctly labeled and therefore are not affected by this voluntary recall. Additionally, no StarKist® tuna products are included in this recall.

StarKist Co. is voluntarily recalling these two SeaSations varieties due to the presence of wheat, which was not declared as an allergen in the ingredient statement. People who are allergic to wheat may run a risk of serious adverse health consequences by consuming this product. To date, no illnesses have been reported – individuals without an allergy to wheat may continue to enjoy this product.

All SeaSations are 100% guaranteed. Consumers can contact the StarKist Consumer Hotline at (800) 252-1587 for further information about the voluntary recall and for instructions on obtaining replacement product. StarKist is working with the FDA in issuing this voluntary recall. We regret this inconvenience to our customers and consumers, and we remain committed to providing nutritious products of the highest quality.

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Friday, January 8, 2010

Ammonia Recalled by OnLine Packaging Due to Chemical Hazard

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following products. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Food Club Supreme Clean Clear Ammonia

Units: About 75 bottles

Manufacturer: OnLine Packaging Inc., of Plover, Wis.

Hazard: The bottle, which is labeled as containing ammonia, actually contains household bleach. The mislabeling of the bottles can pose a chemical hazard to consumers. If bleach is accidentally mixed with ammonia or acid, irritating or toxic gases could be produced.

Incidents/Injuries: None reported.

Description: This recall involves Food Club Supreme Clean Clear Ammonia that is packaged in a 64 ounce white bottle with the date code 232 stenciled on the lower shoulder of the bottle.

Sold at: Piggly Wiggly Midwest stores from August 2009 through September 2009 for about $1.50.

Manufactured in: United States

Remedy: Consumers should immediately return the product to Piggly Wiggly for a full refund or dispose of the bleach in accordance with state and local requirements.

Consumer Contact: For additional information, contact OnLine Packaging at (800) 398-8177 between 9 a.m. and 4 p.m. CT.

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Thursday, December 31, 2009

Publix Issues Allergy Alert on Pecans in Publix Pumpkin Pecan Streusel Pie

(BUSINESS WIRE)--Publix Super Markets is issuing a voluntary recall for Publix Pumpkin Pecan Streusel Pie, because it was mislabeled and may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of allergic reaction if they consume this product. Product was prepared at Publix stores for retail sale between November and December 2009. The recalled product has a UPC number of: 002-95118-20399-7 and is packaged in a 30 ounce plastic container. The name of the product describes the product as “Pumpkin Pecan Streusel Pie.” The ingredient statement on the label does not declare pecan, which is an ingredient in the pie. The mislabeled pies were distributed in Alabama, Florida, Georgia, Tennessee and South Carolina.

“As part of our commitment to food safety and in cooperation with the FDA, we are issuing this voluntarily recall,” said Maria Brous, Publix director of media and community relations. “Since customers may still have these pies in their homes, we wanted to take every precaution to make them aware of the pecan as an ingredient. To date, there have been no reported cases of illness. Consumers who have purchased the product in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Consumer Relations department at 1-800-242-1227 or by visiting our website at www.publix.com.”

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Monday, December 7, 2009

College Inn Initiates Voluntary Recall of Select Canned Chicken Broth Products due to Mislabeling

As a precautionary measure, due to mislabeling, College Inn is initiating a voluntary recall of College Inn® No MSG Chicken Broth sold in individual 14 ½ oz cans.

All other sizes and varieties of College Inn® Chicken Broth are correctly labeled and therefore are not affected by this voluntary recall.

College Inn is voluntarily recalling College Inn® No MSG Chicken Broth in individual 14 ½ oz cans due to the presence of wheat (an allergen) which was not declared in the ingredient statement. Also, the label incorrectly states that the product does not contain Monosodium Glutamate (MSG). The following product is subject to the voluntary recall:

College Inn® No MSG Chicken Broth Individual 14 ½ oz cans All Dates
(Only products labeled "No MSG")

People who are allergic to wheat may run a risk of serious adverse health consequences by consuming this product. To date, no illnesses have been reported in connection with this mislabeling.

Individuals without an allergy to wheat and without a sensitivity to Monosodium Glutamate may continue to enjoy this product.

College Inn products are 100% guaranteed. Consumers can visit www.CollegeInn.com, or contact its Consumer Hotline at (800) 552-7684 for further information about the voluntary recall and for instructions on obtaining replacement product. College Inn values the health and well-being of its consumers, and regrets this situation.

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